PowerMidline Catheter

K153393 · C.R. Bard, Inc. · PND · Jun 28, 2016 · General Hospital

Device Facts

• Record ID: K153393
• Device Name: PowerMidline Catheter
• Applicant: C.R. Bard, Inc.
• Product Code: PND · General Hospital
• Decision Date: Jun 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerMidline™ Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Device Story

PowerMidline™ Catheters are peripherally placed, radiopaque, body-softening polyurethane catheters; feature kink-resistant, reverse-taper design. Available in 3F and 4F single-lumen configurations; 20 cm trimmable lengths. Used for short-term (<30 days) vascular access; inserted percutaneously via modified Seldinger technique with guidewire. Compatible with power injectors for contrast media administration. Operated by clinicians in clinical settings. Output is vascular access for fluid/therapy delivery and blood sampling. Benefits include reliable short-term peripheral access and power injection capability.

Clinical Evidence

Bench testing only. Tests included dimensional characterization, tensile strength, leak/burst pressure, priming volume, radiopacity (ASTM F640-79), power injection flow rates, tip displacement, and cyclic kink. Biocompatibility/sterilization testing per ISO 10993-5, 7, and 10. Risk management per ISO 14971.

Technological Characteristics

Materials: Polyurethane (shaft, junction, extension leg, luer hub), Acetal Resin (clamp). Design: Kink-resistant, reverse-taper, radiopaque. Dimensions: 3F/4F, 20cm length. Sterilization: 100% Ethylene Oxide (SAL 10^-6). Standards: ISO 10555-1, ISO 10993, ASTM F640-79.

Indications for Use

Indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. Suitable for any patient population, contingent upon vascular anatomy and procedure appropriateness.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• CT Midline (K141151)

Reference Devices

• 4 F Single Lumen (SL) PowerPICC Catheter (K070996)
• 3 F Single Lumen (SL) PowerPICC SV Catheter (K102159)

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

June 28, 2016

C.R. Bard, Inc. Bard Access Systems. Inc. Mr. Casey Coombs Regulatory Affairs Specialist II 605 North 5600 West Salt Lake City, Utah 84116

Re: K153393

Trade/Device Name: PowerMidline™ Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: May 26, 2016 Received: May 27, 2016

Dear Mr. Coombs:

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.

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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 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 [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 yours,

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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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K153393

Device Name PowerMidline™ Catheters

Indications for Use (Describe)

The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.

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)

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# AC

## 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: | Mr. Casey Coombs<br>[phone]<br>[phone]<br>27 June 2016 | | |
| Subject<br>Device | Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code:<br>Regulation: | PowerMidline™ Catheter<br>Midline Catheter<br>Intravascular Catheter<br>PND<br>21 CFR §880.5200 | | |
| Predicate/<br>Reference<br>Devices | Predicate Device:<br>Classification:<br>Premarket Notification:<br>Manufacturer: | CT Midline<br>LJS, 21 CFR §880.5970, Percutaneous, implanted,<br>long-term intravascular catheter<br>K141151<br>Medcomp (Medical Components, Inc.) | | |
| | Reference Device:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | 4 F Single Lumen (SL) PowerPICC Catheter<br>Percutaneous, implanted, long-term intravascular<br>catheter<br>K070996<br>Bard Access Systems, Inc. | | |
| | Reference Device:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | 3 F Single Lumen (SL) PowerPICC SV Catheter<br>Percutaneous, implanted, long-term intravascular<br>catheter<br>K102159<br>Bard Access Systems, Inc. | | |
| Device<br>Description | | Bard Access Systems, Inc.'s (BAS) PowerMidline™ catheters are a family of<br>peripherally placed catheters made from radiopaque body-softening<br>polyurethane materials. Each PowerMidline™ catheter is designed with kink-<br>resistant, reverse taper design. The PowerMidline™ catheters are offered in a<br>3 F Single Lumen (SL) and 4 F Single Lumen (SL) configuration for reliable | | |

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| Device<br>Description | short term (less than 30 days) vascular access. These catheters are offered in<br>20 cm trimmable lengths. The PowerMidline™ catheters are suitable for use<br>with power injectors. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PowerMidline™ Catheter is intended for short term peripheral access for<br>selected intravenous therapies, blood sampling, and power injection of<br>contrast media. |
| Indications For<br>Use | The PowerMidline™ Catheters are indicated for short term access to the<br>peripheral venous system for selected intravenous therapies, blood sampling,<br>and power injection of contrast media. These catheters may be used for any<br>patient population with consideration given to adequacy of vascular anatomy<br>and appropriateness of the procedure. The PowerMidline™ Catheters are<br>suitable for use with power injectors. |

Technological characteristics of the subject PowerMidline™ Catheters are substantially equivalent with respect to basic design and function to those of the cited predicate and reference devices. The differences are not critical to the intended use of the device and do not raise new or different questions regarding safety or effectiveness.

The following table provides a comparison of the technological characteristics between the subject and predicate/reference devices in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

| | Subject and Predicate/Reference Device Comparison Table | | | | |
|---------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Attribute | Subject Device<br>PowerMidline™<br>Catheter | Predicate<br>Device - CT<br>Midline<br>(K141151) | Reference<br>Device - 3 F SL<br>PowerPICC SV<br>Catheter<br>(K102159) | Reference<br>Device - 4 F SL<br>PowerPICC<br>Catheter<br>(K070996) |
| Technological<br>Characteristics | Intended Use | Same as<br>predicate/<br>reference<br>devices | The CT Midline<br>is intended to<br>access the<br>vascular system<br>for<br>administration<br>of fluids<br>intravenously,<br>blood sampling,<br>and power<br>injection of<br>contrast media. | The 3 F SL<br>PowerPICC SV<br>Catheter is<br>intended to<br>access the<br>vascular system<br>for<br>administration<br>of fluids<br>intravenously,<br>blood sampling,<br>and power<br>injection of<br>contrast media. | The 4 F SL<br>PowerPICC<br>Catheter is<br>intended to<br>access the<br>vascular system<br>for<br>administration<br>of fluids<br>intravenously,<br>blood sampling,<br>and power<br>injection of<br>contrast media. |
| | Duration of<br>Use | Same as<br>predicate CT<br>Midline | Short term (<30<br>days) | Short term<br>(<30days) or<br>long term<br>(>30days) | Short term<br>(<30days) or<br>long term<br>(>30days) |
| | Means of<br>Insertion | Same as<br>predicate/<br>reference<br>devices | Percutaneous,<br>using Modified<br>Seldinger<br>Technique and<br>guidewire | Percutaneous,<br>using Modified<br>Seldinger<br>Technique and<br>guidewire | Percutaneous,<br>using Modified<br>Seldinger<br>Technique and<br>guidewire |
| Subject and Predicate/Reference Device Comparison Table | | | | | |
| | Attribute | Subject Device<br>PowerMidline™<br>Catheter | Predicate<br>Device - CT<br>Midline<br>(K141151) | Reference<br>Device - 3 F SL<br>PowerPICC SV<br>Catheter<br>(K102159) | Reference<br>Device - 4 F SL<br>PowerPICC<br>Catheter<br>(K070996) |
| Technological<br>Characteristics | Tip Placement<br>Location | Same as<br>predicate CT<br>Midline | Peripheral<br>venous system,<br>with catheter tip<br>terminating prior<br>to the axilla | Central venous<br>system, with<br>lower 1/3 of the<br>Superior Vena<br>Cava (SVC)<br>preferred | Central venous<br>system, with<br>lower 1/3 of the<br>Superior Vena<br>Cava (SVC)<br>preferred |
| | Insertion Site | Same as<br>predicate/<br>reference<br>devices | Peripheral | Peripheral | Peripheral |
| | Catheter Base<br>Materials | Same as<br>predicate/<br>reference<br>devices | Shaft Tubing<br>Polyurethane | Shaft Tubing<br>Polyurethane | Shaft Tubing<br>Polyurethane |
| | | | Catheter<br>Junction<br>Polyurethane | Catheter<br>Junction<br>Polyurethane | Catheter<br>Junction<br>Polyurethane |
| | | | Extension Leg<br>Polyurethane | Extension Leg<br>Polyurethane | Extension Leg<br>Polyurethane |
| | | | Luer Hub<br>Polyurethane | Luer Hub<br>Polyurethane | Luer Hub<br>Polyurethane |
| | | | Extension Leg<br>Clamp<br>Acetal Resin | Extension Leg<br>Clamp<br>Acetal Resin | Extension Leg<br>Clamp<br>Acetal Resin |
| | Catheter<br>Proximal<br>Configuration | Same as<br>predicate/<br>reference<br>devices | Luer<br>Connection | Luer<br>Connection | Luer<br>Connection |
| | Catheter<br>Distal<br>Configuration | Same as<br>predicate/<br>reference<br>devices | Open Ended | Open Ended | Open Ended |
| | Catheter<br>Dimensions | 3 F SL x 20 cm<br>usable length<br>4 F SL x 20 cm<br>usable length | 4 F SL x 20 cm<br>usable length<br>5 F DL x 20 cm<br>usable length | 3 F SL x 45 cm<br>usable length | 4 Fr SL x 55 cm<br>usable length |
| | Number,<br>Shape of<br>Lumens | Same as single<br>lumen predicate/<br>reference<br>devices | Single Lumen,<br>round<br>Double Lumen,<br>double D | Single Lumen,<br>round | Single Lumen,<br>round |
| | Subject and Predicate/Reference Device Comparison Table | | | | |
| Technological<br>Characteristics | Attribute | Subject Device<br>PowerMidline™<br>Catheter | Predicate<br>Device - CT<br>Midline<br>(K141151) | Reference<br>Device - 3 F SL<br>PowerPICC SV<br>Catheter<br>(K102159) | Reference<br>Device - 4 F SL<br>PowerPICC<br>Catheter<br>(K070996) |
| | Depth<br>Markings | Same as<br>reference<br>devices | Number every 5<br>cm and depth<br>mark every cm | "0" depth<br>indicator located<br>1 cm from<br>catheter<br>junction on<br>reverse taper<br>shaft tubing;<br>catheter marked<br>every 1 cm, with<br>numeric<br>indicators every<br>5 cm. | "0" depth<br>indicator located<br>1 cm from<br>catheter<br>junction on<br>reverse taper<br>shaft tubing;<br>catheter marked<br>every 1 cm, with<br>numeric<br>indicators every<br>5 cm. |
| | Pre-inserted<br>Stylet<br>Configuration | Same as<br>predicate/<br>reference<br>devices | Stiffening stylet | Stiffening stylet | Stiffening stylet |
| | Power<br>Injection<br>Maximum<br>Flow Rate | 3 F SL = 3 mL/s<br>4 F SL = 7 mL/s | 4 Fr SL = 5<br>mL/sec<br>5 Fr DL = 7<br>mL/sec | 1 mL/s | 5 mL/s |
| | Sterility | Same as<br>predicate/<br>reference<br>devices | 100% Ethylene<br>Oxide, SAL of<br>10-6 | 100% Ethylene<br>Oxide, SAL of<br>10-6 | 100% Ethylene<br>Oxide, SAL of<br>10-6 |

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The indications for use statement is different between the subject device and predicate device. Specifically, the subject device indications for use includes a statement indicating that the device may be used with any patient population when consideration is given to adequacy of vascular anatomy and appropriateness of the procedure, whereas the predicate device indications for use does not include this statement. This difference in the indications for use does not alter the intended use of the device (i.e., access to the vascular system for administration of fluids intravenously, blood sampling, and power injection of contrast media). The purpose of this information is to specify that prior to use of the subject device, the user should consider the patient's vascular anatomy and appropriateness of using the subject device for the intended procedure. The statement does not prescribe a different general purpose or function of the device, nor does it prescribe a different patient population, therapeutic or diagnostic use of the subject device compared to the predicate device. Therefore, this difference in indications for use between the subject and predicate devices does not raise different questions of equivalence.

### Performance Tests

The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate/reference devices. Additionally, when technological characteristics between the subject and predicate/reference devices were found to be identical, results of performance testing conducted on the predicate/reference devices were applied to the subject device. The following table identifies the performance tests completed on the subject device, including the standards associated to each test.

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| | Testing Completed | ISO Standard / FDA Guidance /<br>BAS Protocols Utilized |
|----------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Tests | Device Dimensional<br>Characterization | |
| | Catheter Assembly Tensile | ISO 10555-1: 2013, Sterile, single-<br>use intravascular catheters, Part 1:<br>General requirements |
| | Catheter Assembly Leak | |
| | Burst Pressure Without Power<br>Injection | |
| | Burst Pressure Post Power Injection<br>Gravity Flow | ISO 10555-1: 2013, Sterile, single-<br>use intravascular catheters, Part 1:<br>General requirements |
| | Tensile, Modulus and Elongation<br>Requirements | Guidance on Premarket Notification<br>[510(k)] Submission for Short-Term<br>and Long-Term Intravascular<br>Catheters, March 16, 1995 |
| | Priming Volume | Guidance on Premarket Notification<br>[510(k)] Submission for Short-Term<br>and Long-Term Intravascular<br>Catheters, March 16, 1995 |
| | Catheter Radiopacity | BAS Internal Protocols/Procedures<br>ASTM F640-79 (reapproved 2000),<br>Standard Test Methods for<br>Radiopacity of Plastics for Medical<br>Use |
| | Power Injection Testing | ISO 10555-1: 2013, Sterile, single-<br>use intravascular catheters, Part 1:<br>General requirements |
| | Tip Displacement During Power<br>Injection | BAS Internal Protocols/Procedures |
| | Catheter Cyclic Kink | BAS Internal Protocols/Procedures |

The following sterilization and biological tests were also performed on the subject device:

- . Sterilant Residual Testing - ISO 10993-7: 2008, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals
- . Cytotoxicity - ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Sensitization/Irritation ISO 10993-10: 2010, Biological evaluation of . medical devices – Part 10: Tests for irritation and skin sensitization

The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate and reference devices.

Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices - Application of risk management to medical devices.

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## Summary of Substantial Equivalence

Based on the intended use, technological characteristics, and performance testing, the subject PowerMidline™ Catheters meet the requirements that are considered sufficient for the intended use and are therefore substantially equivalent to the predicate and reference devices cited.