PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set

K171735 · C.R. Bard, Inc. · PTI · Aug 8, 2017 · General Hospital

Device Facts

• Record ID: K171735
• Device Name: PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
• Applicant: C.R. Bard, Inc.
• Product Code: PTI · General Hospital
• Decision Date: Aug 8, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Both the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory, are intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

Device Story

Infusion sets with non-coring Huber needles; used to access surgically implanted vascular ports for fluid/drug delivery and blood sampling. PowerLoc® MAX supports power injection of contrast media. Devices feature manual needle-stick prevention mechanisms (shielding). Operated by healthcare practitioners in clinical settings. Stabilization accessory assists needle placement. Output is fluid delivery or blood withdrawal. Benefits include reduced risk of accidental needlestick injuries and reliable vascular access.

Clinical Evidence

Bench testing only. Testing confirmed that kit components maintain biological safety and functional efficacy after ethylene oxide sterilization. Risk management (FMEA) performed per ISO 14971:2012.

Technological Characteristics

Non-coring right angle Huber needles; stainless steel needles; PVC tubing; polycarbonate/styrene-butadiene safety components. Ethylene Oxide sterilization (SAL 10^-6). Single-use. Manual needle-stick prevention mechanism. Sizes: 19G, 20G, 22G. Stabilization accessory (polycarbonate/polypropylene).

Indications for Use

Indicated for patients requiring access to surgically implanted vascular ports for fluid/drug administration and blood sampling. PowerLoc® MAX is also indicated for power injection of contrast media (up to 5 ml/s for 19G/20G, 2 ml/s for 22G) when used with compatible ports. SafeStep® is indicated for port septum insertion and fluid infusion. Both include manual needle-stick prevention features.

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 (K153440)
• SafeStep® Huber Needle Set (K153440)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2017

C.R. Bard. Inc. Jeremy Tidwell Quality/Regulatory Specialist 605 North 5600 West Salt Lake Citv. Utah 84116

Re: K171735

Trade/Device Name: PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle. Regulatory Class: Class II Product Code: PTI Dated: July 11, 2017 Received: July 13, 2017

Dear Jeremy Tidwell:

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 of medical device-

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# James P. Bertram -S

for

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K171735

Device Name

PowerLoc® MAX Power-Injectable Infusion Set

## Indications for Use (Describe)

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 which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.

The PowerLoc® MAX Power-Injectable 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 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt"> <span style="font-family:Wingdings">✓</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span> <span style="font-size:10pt"> <span>□</span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *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:

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# Indications for Use

510(k) Number (if known) K171735

Device Name SafeStep® Huber Needle Set

#### Indications for Use (Describe)

The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The 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)

| <div> <span style="font-size:10pt"> <span style="font-family:Wingdings"> <span style="font-size:12pt">☑</span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:10pt"> <span style="font-family:Arial"> <span style="font-size:12pt">☐</span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### 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 [e-mail]

"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."

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# 510(k) Summary

## 21 CFR 807.92(a)

| General Provisions | Submitter Name:<br>Address:<br>Contact Person:<br>Telephone Number:<br>Fax Number:<br>Date of Preparation: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116<br>Jeremy Tidwell<br>Quality/Regulatory Affairs Specialist<br>801-522-5665<br>801-522-4969<br>August 4, 2017 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Devices | Subject Trade Name:<br>Common Name:<br>Requlation Name:<br>Product Code:<br>Regulation:<br>Regulatory Class:<br>Classification Panel: | PowerLoc® MAX Power-Injectable Infusion Set<br>Huber Needle Intravascular Infusion Set Kit<br>Non-Coring (Huber) Needle<br>PTI<br>21 CFR §880.5570<br>General Hospital |
| | Subject Trade Name:<br>Common Name:<br>Requlation Name:<br>Product Code:<br>Regulation:<br>Regulatory Class:<br>Classification Panel: | SafeStep® Huber Needle Set<br>Huber Needle Intravascular Infusion Set Kit<br>Non-Coring (Huber) Needle<br>PTI<br>21 CFR §880.5570<br>General Hospital |
| | Predicate Trade Name:<br>Premarket Notification:<br>Manufacturer:<br>Common Name:<br>Regulation Name:<br>Product Code:<br>Regulation:<br>Regulatory Class:<br>Classification Panel: | PowerLoc® MAX Power-Injectable Infusion Set<br>K153440<br>Bard Access Systems, Inc.<br>Huber Needle Intravascular Administration Set<br>Intravascular Administration Set<br>FPA<br>21 CFR §880.5440<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>General Hospital |
| Predicate Devices | Predicate Trade Name:<br>Premarket Notification:<br>Manufacturer:<br>Common Name:<br>Requlation Name:<br>Product Code:<br>Regulation:<br>Regulatory Class:<br>Classification Panel: | SafeStep® Huber Needle Set<br>K153440<br>Bard Access Systems, Inc.<br>Huber Needle Intravascular Administration Set<br>Intravascular Administration Set<br>FPA<br>21 CFR §880.5440<br>General Hospital |

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| Purpose Statement | The purpose of this submission is to clear the subject devices (i.e., PowerLoc® MAX Power-<br>Injectable Infusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory)<br>in new packaging configurations that include additional kit components, all of which are legally<br>marketed devices. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Descriptions | PowerLoc® MAX Power-Injectable Infusion Set<br>The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion<br>set with a non-coring Huber type right angle needle and a manually activated needle-stick<br>prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding<br>the needle. The device also includes an integrated extension set consisting of infusion tubing, a<br>non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and<br>base. It is used to access surgically implanted vascular ports and is indicated for use in the<br>administration of fluids and drugs, as well as blood sampling.<br>The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast<br>media into the central venous system only through an implanted port that is also indicated for power<br>injection. The maximum 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. The PowerLoc® MAX Power-Injectable Infusion Set<br>is offered with and without a Y-site.<br>SafeStep® Huber Needle Set<br>The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a<br>needlestick prevention feature, designed for use with a vascular access infusion system. The device<br>also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap,<br>female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with<br>conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as<br>a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick<br>injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-<br>site.<br>Stabilization accessory<br>The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX<br>Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the<br>subject devices. It is placed centrally over the implanted port so that the base surrounds the<br>implanted port under the skin. The infusion set needle handle is pressed down until the needle has<br>entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization<br>accessory is then discarded per hospital protocol. |
| Intended Use | Both the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set<br>with or without the stabilization accessory, are intended for use in the administration of fluids and<br>drugs, as well as blood sampling through surgically implanted vascular ports. |
| Indications For Use | PowerLoc® MAX Power-Injectable Infusion Set<br>The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-<br>coring right angle needle and manually activated needle stick prevention safety mechanism which<br>reduces the risk of accidental needlestick injuries by shielding the needle. The needle is used to<br>access surgically implanted vascular ports.<br>The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids<br>and drugs, as well as blood sampling through surgically implanted vascular ports. |

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| | When used with ports that are indicated for power injection of contrast media into the central venous<br>system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of<br>contrast media. For power injection of contrast media, the maximum recommended infusion rate at<br>11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles. | | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use<br>Cont. | SafeStep® Huber Needle Set<br>The SafeStep® Huber Needle Set is a device intended for insertion into the septum of a<br>subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® Huber<br>Needle safety feature is manually activated during needle removal, and is designed to aid in the<br>prevention of accidental needlesticks. | | |
| | Technological characteristics including design and function of the subject devices, the PowerLoc®<br>MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set with or without the stabilization<br>accessory are the same as those of the predicate devices, PowerLoc® MAX Power-Injectable<br>Infusion Set and SafeStep® Huber Needle Set with or without the stabilization accessory.<br>The following table provides a comparison between the technological characteristics of the subject<br>and predicate device:<br>Comparison between subject PowerLoc® MAX Power-Injectable Infusion Set (with | | |
| | or without the stabilization accessory) and the predicate PowerLoc® MAX Power- | | |
| | Device<br>Attribute | Subject:<br>PowerLoc® MAX Power-<br>Injectable Infusion Set (with or<br>without the stabilization<br>accessory) | Predicate K153440:<br>PowerLoc® MAX Power-Injectable<br>Infusion Set (with or without the<br>stabilization accessory) |
| | Owner | Bard Access Systems, Inc. | Bard Access Systems, Inc. |
| Technological<br>Characteristics | Product Code | PTI<br>21 CFR 880.5570<br>Non-Coring Huber Needle | FPA<br>21 CFR 880.5440<br>Set, Administration, Intravascular |
| | Review<br>Branch | Center For Devices and<br>Radiological Health (CDRH) | Center For Devices and Radiological<br>Health (CDRH) |
| | 510k Status | Subject of this Premarket<br>Notification | K153440<br>Concurrence Date: August 18, 2016 |
| | Intended Use | Same as predicate. | The PowerLoc® MAX Power-Injectable<br>Infusion Set is intended for use in the<br>administration of fluids and drugs, as well<br>as blood sampling through surgically<br>implanted vascular ports. |
| | Indications for<br>Use | Same as predicate. | The PowerLoc® MAX Power-Injectable<br>Infusion Set is an intravascular<br>administration set with a non-coring right<br>angle needle and manually activated<br>needle stick prevention safety mechanism<br>which reduces the risk of accidental<br>needlestick injuries by shielding the<br>needle. The needle is used to access |
| | | | |
| Technological<br>Characteristics<br>Cont. | Indications for<br>Use<br>Cont. | | surgically implanted vascular ports.<br>The PowerLoc® MAX Power-Injectable<br>Infusion Set is indicated for use in the<br>administration of fluids and drugs, as well<br>as blood sampling through surgically<br>implanted vascular ports.<br>When used with ports that are indicated for<br>power injection of contrast media into the<br>central venous system, the PowerLoc®<br>MAX Power-Injectable Infusion Set is also<br>indicated for power injection of contrast<br>media. For power injection of contrast<br>media, the maximum recommended<br>infusion rate at 11.8 cPs is 5 ml/s for 19<br>gauge and 20 gauge needles, and 2 ml/s |
| | General<br>Device<br>Description | Same as predicate. | for 22 gauge needles.<br>The PowerLoc® MAX Power-Injectable<br>Infusion Set is a non-coring Huber needle<br>infusion set with an integral needle stick<br>prevention safety feature.<br>The stabilization device is an accessory to |
| | | | the Huber needle infusion sets which is<br>placed centrally over the implanted port to<br>assist in the placement of the Huber<br>needle in the implanted port. |
| | Y-Site | Same as predicate. | The PowerLoc® MAX Power-Injectable<br>Infusion Set is offered either with or without<br>a Y-site. |
| | Duration of<br>Use | PowerLoc® MAX: Same as<br>predicate.<br>Stabilization accessory: Same<br>as predicate. | PowerLoc® MAX: Externally<br>communicating device with an indirect<br>blood path with a contact duration of >24<br>hours to 30 days.<br>Stabilization accessory: A single-use |
| | | | device used only for the duration of the<br>insertion of the needle into the port.<br>Surface device, skin only, limited exposure<br>(≤24 hours). |
| | | Same as predicate. | Huber Needle<br>Stainless Steel |
| | Device<br>Materials | Same as predicate. | Adhesive<br>UV Adhesive |
| | | Same as predicate. | Safety Guard Base<br>Styrene, Butadine, Copolymer or<br>Polycarbonate |
| | | | |
| | | Same as predicate. | Needle Lubricant<br>Medical Grade Silicones |
| | | Same as predicate. | Safety Guard Inner Base<br>Styrene, Butadiene, Copolymer<br>Insert Colorants:<br>Yellow<br>Brown<br>Black |
| Technological<br>Characteristics<br>Cont. | Device<br>Materials<br>Cont. | Same as predicate. | Safety Guard Sleeve<br>Stainless Steel |
| | | Same as predicate. | Safety Guard Shutter<br>Stainless Steel |
| | | Same as predicate. | Pad-print Ink<br>Ink |
| | | Same as predicate. | Needle Cover<br>Polyethylene |
| | | Same as predicate. | Safety Guard Handle<br>Styrene, Butadiene, Copolymer |
| | | Same as predicate. | Comfort Pad<br>Polyethylene |
| | | Same as predicate. | Administration Tubing<br>PVC |
| | | Same as predicate. | Female Locking Luer Connection<br>PVC |
| | | Same as predicate. | Adaptable Y-Injection Site Female Locking<br>Luer Connection<br>PVC |
| | | Same as predicate. | Non-vented Male Luer Cap<br>Acrylonitrile butadiene styrene |
| | | Same as predicate. | Pinch Clamps<br>Polypropylene<br>Colorants<br>Yellow<br>Brown<br>Black |
| | | Same as predicate. | Stabilization accessory<br>Stabilizer<br>Polycarbonate |

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| Technological<br>Characteristics<br>Cont. | | Same as predicate. | Stabilization accessory<br>Needle Handle<br>Polypropylene | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------|--------|
| | Sterility<br>Method | Same as predicate. | Ethylene Oxide | | | |
| | Sterility<br>Assurance<br>Level (SAL) | Same as predicate. | SAL 10-6…