PowerPICC Provena Catheters

K162443 · C.R. Bard, Inc. · LJS · Oct 25, 2016 · General Hospital

Device Facts

• Record ID: K162443
• Device Name: PowerPICC Provena Catheters
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Oct 25, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPICC Provena Catheters are intended for short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Device Story

PowerPICC Provena Catheters are sterile, single-use, peripherally inserted central catheters (PICC) providing vascular access for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. Devices feature a reverse taper design, radiopaque polyurethane construction, and depth indicators. Available in 3F single lumen and 4F dual lumen configurations. Used in clinical settings for short- or long-term (>30 days) access. Inserted percutaneously using a peel-away sheath introducer. Healthcare providers use the device to deliver fluids or contrast media and monitor pressure; the catheter's purple colorant differentiates it from other power-injectable devices. Benefits include reliable central venous access with power injection capability.

Clinical Evidence

Bench testing only. No clinical data. Verification and validation testing performed per 21 CFR 820.30, including biocompatibility (ISO 10993/ISO 10555-1), mechanical testing (tensile, burst, leak, collapse, hemolysis, kink, flow rate), and power injection performance.

Technological Characteristics

Radiopaque polyurethane (polycarbonate polyurethane shaft/extension legs) catheter. Reverse taper design. Open-ended distal configuration. Single or dual lumen. Sterilized. Dimensions vary by French size. No software or electronic components.

Indications for Use

Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. Recommended lumen size for pressure monitoring is 20 gauge or larger.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• PowerPICC SV Catheter (K102159)

Reference Devices

• PowerPICC EtOH Catheter (K151985)
• PowerPICC Catheter (K053501)

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

October 25, 2016

C.R. Bard, Inc. Mr. Bryan Stone Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K162443

Trade/Device Name: PowerPICC Provena Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 28, 2016 Received: September 30, 2016

Dear Mr. Stone:

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 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,

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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

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## Indications for Use

510(k) Number (if known)

K162443

Device Name PowerPICC Provena Catheters

#### Indications for Use (Describe)

The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

| Catheter Size | Maximum Flow Rate |
|------------------|-------------------|
| 3 F Single Lumen | 3 mL/sec |
| 4 F Dual Lumen | 5 mL/sec |

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|

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# 510(k) Summary

21 CFR 807.92(a)

| General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Bryan Stone<br>Regulatory Affairs Specialist, II |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date of Preparation: | September 29, 2016 |
| Subject Device | Trade Name(s): | PowerPICC Provena Catheters |
| | Common Name: | Peripherally Inserted Central Catheter (PICC) |
| | Classification Name: | Percutaneous, Implanted, Long-term Intravascular<br>Catheter |
| | Product Code/Regulation: | LJS/21 CFR §880.5970 |
| Predicate<br>Devices | Predicate Trade Name: | PowerPICC SV Catheter |
| | Classification Name: | Percutaneous, Implanted, Long-term Intravascular<br>Catheter |
| | Premarket Notification: | K102159 |
| | Manufacturer: | Bard Access Systems, Inc. |
| References<br>Devices | Reference Trade Name: | PowerPICC EtOH Catheter |
| | Classification Name: | Percutaneous, Implanted, Long-term Intravascular<br>Catheter |
| | Premarket Notification: | K151985 |
| | Manufacturer: | Bard Access Systems, Inc. |
| | Reference Trade Name: | PowerPICC Catheter |
| | Classification Name: | Percutaneous, Implanted, Long-term Intravascular<br>Catheter |
| | Premarket Notification: | K053501 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device<br>Description | Bard Access Systems, Inc.'s PowerPICC Provena Catheters are sterile, single use<br>devices designed to provide access to the patient's vascular system. The devices are | |

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| | intended for short- or long-term use (>30 days) to sample blood and administer fluids<br>intravenously. The catheters are capable of central venous pressure monitoring, and<br>can withstand power injection of contrast media. The catheters are peripherally<br>inserted central catheters (PICC) and utilize the same placement technique as the<br>predicate devices. | | | | | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | The subject devices included in this notification are of varying French size and<br>catheter configuration types, as summarized in the table below. | | | | | | |
| | Summary of Subject Devices | | | | | | |
| | French size (Number of Lumens)<br>Catheter Configuration | | | | | | |
| | PowerPICC Provena Catheters | | 3 French Single Lumen (SL) | | | | |
| | 4 French Dual Lumen (DL) | | | | | | |
| | The following device descriptors apply to all French sizes and configurations of the<br>subject catheters: | | | | | | |
| | ● | | | Catheters are open-ended, radiopaque polyurethane; | | | |
| | ● | Catheters have a reverse taper design; | | | | | |
| | Catheter shaft tubing is marked with depth indicators, with "0" indicated to<br>●<br>serve as a reference for the catheter insertion point; | | | | | | |
| | Purple colorant is included in the catheter material to provide the catheter with<br>●<br>an appearance that allows the end user to differentiate Bard's power<br>injectable catheters from other manufacturers' power injectable catheters; and | | | | | | |
| | Catheter extension leg, luer hub, junction, and clamp ID tags are printed with<br>●<br>markings to identify the catheter as PowerPICC Provena Catheters, and<br>include information to facilitate proper use of the device. | | | | | | |
| | The subject devices are provided sterile in basic interventional radiology (IR) as well<br>as basic, full, and max barrier nursing PICC kits with legally marketed components to<br>assist in the placement procedure. These kits are available in both standard and small<br>patient versions. | | | | | | |
| Intended Use | The PowerPICC Provena Catheters are intended for short- or long-term peripheral<br>access to the central venous system for intravenous therapy and blood sampling. | | | | | | |
| Indications For | The PowerPICC Provena Catheters are indicated for short or long-term peripheral<br>access to the central venous system for intravenous therapy, blood sampling, power<br>injection of contrast media, and allows for central venous pressure monitoring. For<br>central venous pressure monitoring, it is recommended that a catheter lumen of 20<br>gauge or larger be used. | | | | | | |
| Use | | Catheter Size | | Maximum Flow Rate | | | |
| | | 3F Single Lumen | | 3 mL/sec | | | |
| | | 4F Dual Lumen | | 5 mL/sec | | | |
| Technological<br>Characteristics | predicate device. | | | Technological characteristics of the subject PowerPICC Provena Catheters are<br>substantially equivalent with respect to basic design and function to those of the cited | | | |

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Key modifications made to the subject device when compared to the predicate device are as follows:

- . Dimensional modifications to the catheter shaft including the reverse taper length and wall thickness of the catheter lumens;
- o Material formulation changes have been made to the subject devices compared to the predicate devices (refer to Comparison Table below);
- . Labeling and packaging modifications due to changes to the commercial name, maximum flow rate, and the addition of small patient packaging kit configurations.

The following table provides a comparison between the subject and predicate device.

| Subject and Predicate Device Comparison Table | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Subject Device – PowerPICC Provena Catheters | Predicate Device – PowerPICC SV Catheters (K102159) |
| Owner | Same | Bard Access Systems, Inc. |
| Classification | Same | LJS - 21 CFR 880.5970 - Long-Term - Intravascular Catheter |
| 510(k) Status | Subject of this Premarket Notification | K102159 - Concurrence date November 17, 2010 |
| Indications for Use | The PowerPICC Provena catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | The PowerPICC SV catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. |
| | Catheter Size | Maximum Flow Rate |
| | 3F Single Lumen | 3 mL/sec |
| | 4F Dual Lumen | 5 mL/sec |
| | Catheter Size | Maximum Flow Rate |
| | 3F Single Lumen | 1 mL/sec |
| | 4F Dual Lumen | 2.5 mL/sec |
| Commercial Name | PowerPICC Provena Catheters | PowerPICC SV Catheters |
| Catheter Dimensions | 3F Single Lumen x 55 cm | 3F Single Lumen x 45 cm |
| | 4F Dual Lumen x 55 cm | 4F Dual Lumen x 55 cm |
| Duration of Use | Same | Short (<30 days) or long-term (≥30 days) |

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| Means of<br>Insertion | Same | | | Percutaneous using a peel-away sheath Introducer | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|--|
| Insertion Site | Same | | | Peripheral | | | |
| | Catheter Base Materials<br>Shaft Tubing: | | | Catheter Base Materials | | | |
| | | | | Shaft Tubing: | | | |
| | Polycarbonate Polyurethane | | | Polyether Polyurethane | | | |
| Primary<br>Device<br>Materials | Luer Connector: | | | Luer Connector: | | | |
| | Same | | | Polyurethane | | | |
| | Extension Legs: | | | Extension Legs: | | | |
| | Polycarbonate Polyurethane | | | Polyether Polyurethane | | | |
| | Junction | | | Junction | | | |
| | Same | | | Polyether Polyurethane | | | |
| Catheter<br>Proximal<br>Configuration | Same | | | Luer Connection | | | |
| Catheter Distal<br>Configuration | | | Open Ended | | | | |
| Number of<br>Lumens | | | Single Lumen | | | | |
| | | | Dual Lumen | | | | |
| Power<br>Injection<br>Maximum Flow<br>Rate | Catheter Size | Maximum<br>Flow Rate | | Catheter Size | Maximum<br>Flow Rate | | |
| | 3F Single<br>Lumen | 3 mL/sec | | 3F Single Lumen | 1 mL/sec | | |
| | 4F Dual Lumen | 5 mL/sec | | 4F Dual Lumen | 2.5<br>mL/sec | | |
| Sterility | Same | | Provided Sterile | | | | |
| | Both Standard and Small<br>Patient versions in: | | | Standard Kits: | | | |
| Packaging<br>Configurations | Basic ConfigurationFull ConfigurationMax Barrier ConfigurationIR Configuration | | Basic ConfigurationFull ConfigurationMax Barrier ConfigurationIR Configuration | | | | |
| The technological differences listed above, including differences in material<br>formulation and dimensional design, were evaluated using the same test<br>requirements as the predicate devices, as defined in the Risk Assessment. Therefore,<br>these differences in technological characteristics between the subject and predicate<br>devices do not raise different questions of equivalence. | | | | | | | |
| Performance<br>Tests | | | | Verification and validation tests were designed and performed in accordance with<br>Design Controls per 21 CFR §820.30. The following tests were conducted per<br>guidance documents and standards in conjunction with in-house protocols to | | | |

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| Verification /<br>Validation Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility<br>Testing | Tests to confirm that the catheter is free from biological hazard.<br>Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters –<br>1: General requirements Testing Performed includes: Sensitization Cytotoxicity Irritation/Intracutaneous Reactivity Acute Systemic Injection Material-mediated Pyrogenicity Subacute 14 day IV toxicity (Saline) Subacute 14 day IP toxicity (Cottonseed oil) Ames Genotoxicity Mouse Lymphoma Rodent Blood Micronucleus 2 week and 6 week implantation Hemolysis Complement Activation | |
| Cantilever Stiffness<br>Test | Test to characterize the catheter shaft stiffness at the distal section<br>using a cantilever bend technique. Bard internal standards and procedures | |
| Clamp Engagement | Test to confirm that the catheter assembly will not leak when the<br>clamp is engaged. Bard internal standards and procedures and ISO 10555-<br>1:2013 – Sterile Single-Use Intravascular Catheters –<br>1: General requirements | |
| Mechanical<br>Hemolysis Test | Testing to determine the hemolytic properties when blood is<br>aspirated through the catheter assembly. Bard internal standards and procedures | |
| Leak Test | Test to confirm that the catheter assembly will not leak when the<br>distal end of the catheter is occluded. Bard internal standards and procedures and ISO 10555-<br>1:2013 – Sterile Single-Use Intravascular Catheters –<br>1: General requirements | |
| Dimensional Test | Test to measure OD and ID for single lumen catheters and OD and<br>lumen area for dual lumen catheters to ensure compliance with<br>dimensional specification. Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters -<br>1: General requirements | |
| Implantable Length | Test to measure useful length for catheters to ensure compliance<br>with dimensional specification. Bard internal standards and procedures and ISO 10555-<br>1:2013 – Sterile Single-Use Intravascular Catheters –<br>1: General requirements | |
| Extension Leg<br>Length | Test to measure and confirm extension leg length compliance with<br>dimensional specification. Bard internal standards and procedures | |
| Catheter Collapse<br>Test | Test to measure the flow rate of aspiration and demonstrate that<br>the catheter will not collapse under a vacuum. Bard internal standards and procedures and ISO 10555-<br>1:2013 – Sterile Single-Use Intravascular Catheters –<br>1: General requirements | |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds<br>the peak pressure present in the catheter at maximum flow<br>conditions when the distal end is occluded. Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters - Part<br>1: General requirements | |
| OD Swell | Test to confirm that the catheter does not swell beyond twice the<br>size of the labeled OD during power injection. Bard internal standards and procedures | |
| Hydraulic Catheter<br>Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds<br>the peak pressure present in the catheter at maximum flow<br>conditions when the distal end is occluded. Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters - Part<br>1: General requirements | |
| Extension Leg Burst<br>Test | Burst pressure test to confirm the extension leg burst pressure<br>exceeds the peak pressure present in the catheter at maximum<br>flow conditions when the extension leg is occluded. Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters - Part<br>1: General requirements | |
| Power Injection<br>Conditioning | Test to confirm the catheter does not leak or burst as a result of<br>power injections at maximum indicated flow rate. Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters - Part<br>1: General requirements | |
| Tip Stability Test | Test to confirm that the catheter tip remains in the same orientation<br>during power injection (tip pointing in direction of venous flow) at<br>the maximum indicated flow rate. Bard internal standards and procedures | |
| Assembly Tensile<br>Test | Test to demonstrate the peak tensile force of each test piece<br>exceeds the minimum peak tensile force. | |
| Shaft Tensile Test<br>Luer to Extension<br>Leg Tensile Test | ISO 10555-1:2013 – Sterile Single-Use Intravascular<br>Catheters – Part 1: General requirements | |
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus at<br>break. Bard internal standards and procedures and FDA<br>guidance, Guidance on Premarket Notification [510(k)]<br>Submission for Short-Term and Long-Term Intravascular<br>Catheters (March 16, 1995) | |
| Radiopacity | Test to demonstrate catheter radio-detectability. Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters - Part<br>1: General requirements | |
| Suture Wing<br>Integrity Test | Test to measure the maximum force a catheter junction suture<br>wing can withstand prior to break. Bard internal standards and procedures and FDA<br>guidance, Guidance on Premarket Notification [510(k)]<br>Submission for Short-Term and Long-Term Intravascular<br>Catheters (March 16, 1995) | |
| Priming Volume | Test to measure the volume required to prime a full length catheter. FDA guidance, Guidance on Premarket Notification<br>[510(k)] Submission for Short-Term and Long-Term<br>Intravascular Catheters (March 16, 1995) | |
| Gravity Flow | Test to measure the gravity flow performance of a full length<br>catheter. Bard internal s…