Who is the manufacturer of PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set?

Bard Access Systems, Inc. filed the 510(k) submission for PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set (K241353).

What is the FDA product code for PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set?

PTI. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set

K241353 · Bard Access Systems, Inc. · PTI · Nov 27, 2024 · General Hospital

Device Facts

Record ID	K241353
Device Name	PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
Applicant	Bard Access Systems, Inc.
Product Code	PTI · General Hospital
Decision Date	Nov 27, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5570
Device Class	Class 2

Intended Use

PowerLoc™ Max Power Injectable Infusion Set: The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular 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. These devices may be used in any patient population with an implanted vascular port. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 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 into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. These devices may be used in any patient population with an implanted vascular port. Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

Device Story

Non-coring Huber needle and infusion set; includes manually activated needlestick prevention safety mechanism. Accesses subcutaneous vascular ports via septum penetration; provides closed fluid pathway for infusion/blood sampling. PowerLoc™ Max variant supports power injection of contrast media (up to 325 psi) in compatible ports. Used in clinical settings by healthcare providers. Output is fluid delivery or blood sample access. Benefits include safe port access, needlestick injury prevention, and high-pressure contrast media delivery capability.

Clinical Evidence

Bench testing only. No clinical data required. Performance testing included biocompatibility (ISO 10993-1), assembly burst/tensile strength, air leak, flow rate, clamp function, Luer connector testing (ISO 80369-7), particulate matter (USP 788), and needleless Y-site performance. All tests met predetermined acceptance criteria.

Technological Characteristics

Non-coring Huber needle; thermoplastic polyurethane tubing; acetal pinch clamps; silicone lubricant. Sterilized via Ethylene Oxide (SAL 10^-6). Features manually activated safety guard. Luer connectors compliant with ISO 80369-7. Available in 19G, 20G, 22G sizes.

Indications for Use

Indicated for patients with surgically implanted vascular ports requiring infusion of fluids/drugs or blood sampling. PowerLoc™ Max version indicated for power injection of contrast media (up to 325 psi) in ports specifically cleared for such use. SafeStep™ version contraindicated for power or high-pressure injection.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

PowerLoc® MAX Power-Injectable Infusion Set; SafeStep® Huber Needle Set (K171735)

Reference Devices

Similarly marketed device (K060812)

Related Devices

K171735 — PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set · C.R. Bard, Inc. · Aug 8, 2017
K153440 — PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set · C.R. Bard, Inc. · Aug 18, 2016
K242763 — JetCan® Pro Safety Huber Needle · Pfm Medical, Inc. · May 2, 2025
K142590 — All Safe Huber Safety Infusion Set · Nexus Medical, LLC · Jan 16, 2015
K082306 — POWERLOC CLEAR SAFETY INFUSION SET · C.R. Bard, Inc. · Aug 28, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 27, 2024 Bard Access Systems, Inc. Catherine Langford Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116 Re: K241353 Trade/Device Name: PowerLoc™ Max Power Injectable Infusion Set: SafeStep™ Huber Needle Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: October 28, 2024 Received: October 28, 2024 Dear Catherine Langford: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Porsche Bennett Porsche Bennett for David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241353 #### Device Name PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set Indications for Use (Describe) PowerLocTM Max Power Injectable Infusion Set: The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular 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. These devices may be used in any patient population with an implanted vascular port. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 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 into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. These devices may be used in any patient population with an implanted vascular port. Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection. | 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." {4}------------------------------------------------ | Contact Details 21 CFR 807.92(a)(1) | Submitter Name: | Bard Access Systems, Inc. | |-----------------------------------------------|-----------------------------------|----------------------------------------------------------------------------| | | Submitter Address: | 605 North 5600 West Salt Lake City, Utah 84116 USA | | | Contact Telephone: | 801.522.5000 | | | Contact Person: | Catherine Langford Regulatory Affairs Specialist | | | Contact Email | catherine.langford@bd.com | | | Date of Preparation: | 27 November 2024 | | Device Name 21 CFR 807.92(a)(2) | Trade Name: | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set | | | Common Name: | Hypodermic single lumen needle | | | Classification Name: | Non-Coring (Huber) Needle | | | Class: | Class II | | | Regulation Number: | 880.5570 | | | Product Code: | PTI | | | Classification Panel: | General Hospital | | Predicate Device 21 CFR 807.92(a)(3) | Trade Name: | PowerLoc® MAX Power-Injectable Infusion Set; SafeStep® Huber Needle Set | | | Common Name | Hypodermic single lumen needle | | | Classification Name: | Non-Coring (Huber) Needle | | | Class: | Class II | | | Regulation Number: | 880.5570 | | | Product Code: | PTI | | | Premarket Notification Number: | K171735 | # K241353 - 510(k) Summary 21 CFR 807.92(a) ## PowerLoc™ Max Power Injectable Infusion Set: The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion 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. These devices may be used in any patient population with an implanted vascular port. Indications for Use 21 CFR 807.92(a)(5) For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 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 into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. {5}------------------------------------------------ These devices may be used in any patient population with an implanted vascular port. Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Device Description 21 CFR 807.92(a)(4) | PowerLoc™ Max Power Injectable Infusion Set PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non- pyrogenic, for single use only. The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site. SafeStep™ Huber Needle Set The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. These devices may be used in any patient population with an implanted vascular port. Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection. | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Image /page/5/Picture/4 description: The image shows a diagram of the Subject PowerLoc Max Power Injectable Infusion Set (19 GA with Y-site shown). The diagram includes labels for the different parts of the infusion set, such as the female locking luer connection, safety guard handle, administration tubing, adaptable Y-site female locking luer connection, Huber needle, pinch clamps, and non-vented male luer caps. The safety guard base includes the inner base, sleeve, shutter, and comfort pad. {6}------------------------------------------------ Image /page/6/Figure/1 description: The image shows a SafeStep Huber Needle Set (19 GA with needleless Y-site shown). The different parts of the needle set are labeled, including the needleless access connector Y-site, pinch clamps, administration tubing, female locking luer connection, Huber needle, safety guard base, non-vented male luer cap, and safety guard handle. The image also includes text describing the indications for use and comparison of the Huber Needle Set. The text states that the intended use has not changed compared to the predicate. {7}------------------------------------------------ | | Component | SUBJECT DEVICE PowerLoc™ Max Power Injectable Infusion Set SafeStep™ Huber Needle Set | PREDICATE DEVICE (K171735) PowerLoc™ Max Power Injectable Infusion Set SafeStep™ Huber Needle Set | |--|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | | Huber Needle | Same as predicate | Stainless Steel | | | Adhesive | Same as predicate | UV Cured Acrylic | | | Needle Lubricant | Silicone | Silicone | | | Needle Cover | Same as predicate | Polyethylene | | | Safety Guard Base | Same as predicate | Styrene-Butadiene Copolymer or Polycarbonate | | | Safety Guard Inner Based | Same as predicate | Styrene-Butadiene Copolymer + Colorant 19GA (Yellow) 20GA (Brown) 22GA (Black) | | | Safety Guard Sleeve | Same as predicate | Stainless steel | | | Safety Guard Shutter | Same as predicate | Stainless steel | | | Safety Guard Handle | Same as predicate | Styrene-Butadiene Copolymer | | | Safety Guard Comfort Pad | Same as predicate | Polyethylene | | | Administration Tubing | Thermoplastic polyurethane | Polyvinyl chloride | | | Female Locking Luer Connection | Polyvinyl chloride (Type of PVC and dimension) | Polyvinyl chloride | | | Adaptable Y- Injection site Female Locking Luer Connection | Same as predicate | Polyvinyl chloride | | | Non-vented Male Luer Cap | Same as predicate | Acrylonitrile butadiene styrene + White Colorant | | | Pinch Clamp | Acetal (polyoxymethylene) + Colorant 19G: Brown 20G: Yellow 22G: Black | Polypropylene + Colorant 19G: Brown 20G: Yellow 22G: Black | | | Pinch Clamp Ink (PowerLoc™ Max Power Injectable Infusion Set ONLY) | White Ink Black Ink | White Ink Black Ink | | | Needless Access Connector Y-Site | Same as predicate | Polycarbonate | Technological Comparisonison {8}------------------------------------------------ . | (SafeStep™ Huber Needle Set ONLY) | | | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Needless Access Connector Y-Site Valve (SafeStep™ Huber Needle Set ONLY) | Same as predicate | Silicone | | Fundamental Scientific Technology | Same as predicate | The device accesses implanted ports to transport fluid into and out of the central venous system. It utilizes a standard right angle non-coring Huber needle and administration set with a needlestick prevention feature. | | Device Sizes and Tubing Dimensions | Same as predicate | Needle Gauge - 19G, 20G or 22G Needle Length - 0.75 in., 1.00 in., 1.50 in. Clamp Color Guided by ISO 6009 - 19G Brown, 20G Yellow, 22G Black Tubing dimension with needleless Y-site - 4.00 in Tubing dimension without needleless Y-site - 8.00 in | | Product Configurations | Same as predicate | Standalone and convenience kit | | Sterilization Modality | Ethylene Oxide | Ethylene Oxide | | Minimum SAL | Same as predicate | 1 x 10-6 | | Anatomical Site Use | Same as predicate | The site of a surgically implanted vascular port. | | Disposable or Reusable | Same as predicate | Disposable - Single-use device | | Safety Infusion Set Device Components | End Cap Luer Connector Tubing Non-Winged Grip Safety Guard Base Pinch Clamps Needle Needle Handle | End Cap Luer Connector Tubing Non-Winged Grip Safety Guard Base Pinch Clamps Needle Needle Handle | {9}------------------------------------------------ | | Subject Device PowerLoc™ Max Power Injectable Infusion Set | Predicate Device (K171735) PowerLoc™ Max Power Injectable Infusion Set | |--------------|------------------------------------------------------------------|------------------------------------------------------------------------------| | Gauge (G) | Power Injector Flow Rate at 11.8 cPs at 325 psi (2241 kPa) | Power Injector Flow Rate at 11.8 cPs at 325 psi (2241 kPa) | | 19 | Same as predicate | 5 mL/s | | 20 | Same as predicate | 5 mL/s | | 22 | Same as predicate | 2 mL/s | | | Subject Device PowerLoc™ Max Power Injectable Infusion Set SafeStep™ Huber Needle Set | Predicate Device (K171735) PowerLoc™ Max Power Injectable Infusion Set SafeStep™ Huber Needle Set | | |------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Priming Volume (on labeling) | Same as predicate | Without Y-site | 0.3 mL | | | | SafeStep™ with needleless Y-site | 0.7 mL | | | | PowerLoc™ Max with Y-site | 0.4 mL | | Residual Volume | Same as predicate | SafeStep™ with needleless Y-site | <.35 mL | | Connector Types | Same as predicate | Without Y-site | 1 Female Luer lock adapter | | | | SafeStep™ with needleless Y-site | 1 Female Luer lock adapter 1 Needleless Y-site connector | | | | PowerLoc™ Max with Y-site | 1 Female Luer lock 1 Y-site Luer lock connector | Comment 1: The material formulation for the administration tubing and pinch clamps have changed to those currently used in a similarly marketed device (K060812) with the same biological contact and duration. Biocompatibility and performance testing were conducted to demonstrate the differences do not raise new or different questions of safety and effectiveness. Comment 2: The type of PVC material was changed for the female Luer locking connection and there were dimensional changes to the female Luer locking connection to comply with ISO80369-7. Biocompatibility and performance testing; respectively were conducted to demonstrate the differences do not raise new or different questions of safety and effectiveness. {10}------------------------------------------------ In summary, the subject and predicate devices utilize the same fundamental scientific technologies. The subject device is substantially equivalent to the predicate device with respect to components, component materials, and dimensions. In addition, the BD-owned subject and predicate devices were designed in compliance with the same consensus standards. The following performance tests were conducted by or for Bard Access Systems (BD) per guidance documents and standards in conjunction with in-house protocols to establish the performance of the PowerLoc™ Max Power Injectable Infusion Set and SafeStep™ Huber Needle Set, and in determining substantial equivalence to the predicate K171735. All testing passed the predetermined acceptance criteria. | Safety & Performance Tests 21 CFR 807.92(b) | Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Tests to confirm that the catheter is free from biological hazard per testing. A health-based risk assessment per ISO 10993-1 was performed for determining the acceptability of the material for the intended purpose. | | | | Biocompatibility Testing | Testing Performed includes: Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity Subchronic Systemic Toxicity Hemocompatibility | | | Reference Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements | | | | Assembly Burst | Burst pressure test to confirm the assembly burst pressure exceeds the peak pressure at maximum flow conditions. | | | Reference Standard: ISO 8536-4:2019 – Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed | | | | Assembly Tensile | Test to demonstrate the peak tensile force of each assembly exceeds the minimum peak tensile force. | | | Reference Standard: ISO 8536-10:2015 – Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment | | | | Assembly Air Leak | Test to confirm that the assembly will not leak when occluded. | | | Assembly High Pressure Water Leak/Burst (2X) | Test to confirm the PowerLoc™ Max Power Injectable Infusion Set does not leak or burst at maximum indicated flow rate. | | | Reference Standard: ISO 7864:2016: Sterile hypodermic needles for single use – Requirements and test methods | | | | Assembly Occlusion/Flow Rate | Test to confirm minimum flow rates. | | Internal Standard | | | | Clamp Function | Test to confirm that fluids will not pass through tubing when the clamp is engaged. | | | Reference Standard: ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications | | | | Luer Adapter Testing | Testing to ensure that Luer adapters meet requirements for: • Leak • Leak Decay • Stress Cracking • Resistance to Separation from Axial Load • Resistance to Separation from Unscrewing • Resistance to Overriding | | | Reference Standard: USP<788>: Sizing and Counting Particulate Matter | | | | Particulate Testing | Testing to ensure that particulate matter on the catheter post-manufacture is not exceeded for prescribed particle sizes. | | | Reference Standard: Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] (Document Issued July 11, 2008) | | | | Needleless Y- Site Testing | Testing to ensure needleless access connector used in SafeStep™ Huber Needle Set configurations with Y-site meet requirements for: • Microbial Ingress • Valve Activation • Air Introduction Due to Device Connect/Disconnect | | | Reference Standard: ISO 10993-7:2008: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] | | | | Residual Toxicity | Testing to ensure EO residuals are below requirements for any patient with an implanted port. | | | Clinical Testing | Clinical data was not needed to demonstrate substantial equivalence. | | | Technological Comparison to Predicate Device | The subject PowerLoc™ Max Power Injectable Infusion Set and SafeStep™ Huber Needle Set has the same intended use and fundamental technological characteristics as the cited predicate device cleared under K171735. The tubing and clamp materials differ from the predicate device; however, this difference does not alter the intended use of the subject device and does not raise any new or different questions regarding safety or effectiveness when compared to the predicate device. | | | Summary of Substantial Equivalence | Based on the intended use, technological characteristics, and results of performance testing, the subject PowerLoc™ Max Power Injectable Infusion Set and SafeStep™ Huber Needle Set is considered substantially equivalent to the cited predicate device. | | {11}------------------------------------------------