3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology

K180548 · C.R. Bard, Inc (Bard Has Joined Bd) · LJS · Apr 26, 2018 · General Hospital

Device Facts

• Record ID: K180548
• Device Name: 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
• Applicant: C.R. Bard, Inc (Bard Has Joined Bd)
• Product Code: LJS · General Hospital
• Decision Date: Apr 26, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are intended for short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Device Story

Peripherally inserted central catheter (PICC) providing vascular access for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. Device consists of catheter shaft, extension legs, and optional proximal silicone SOLO2 valve. Used in clinical settings (IR, nursing) for short or long-term access. Inserted percutaneously via peel-away sheath introducer. Healthcare providers use the device to deliver fluids or draw blood; the valve (if present) manages fluid flow. Benefits include reliable vascular access and compatibility with power injection protocols.

Clinical Evidence

Bench testing only. Performance testing included assembly tensile testing (ISO 10555-1), dimensional characterization, leak decay testing, and hydraulic burst testing. Biocompatibility evaluation conducted per ISO 10993-1. No clinical data presented.

Technological Characteristics

Materials: Polyether Polyurethane (extension legs), Polycarbonate Polyurethane (shaft/junction), Silicone (SOLO2 valve). Design: Peripherally inserted central catheter, single or dual lumen, open-ended distal tip. Connectivity: None. Sterilization: Provided sterile. Standards: ISO 10555-1, ISO 10993-1, BS EN ISO 14971.

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 for use with 20 gauge or larger lumen for pressure monitoring.

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 Provena (K162443)
• PowerPICC Provena Catheters with SOLO2 Valve Technology (K162441)

Reference Devices

• PowerPICC SOLO Catheter (K072230)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 26, 2018

C.R. Bard, Inc (Bard has joined BD) Brvan Stone Associate Manager, Regulatory Affairs 605 North 5600 West Salt Lake City, Utah 84116

Re: K180548

Trade/Device Name: PowerPICC Provena Catheters PowerPICC Provena Catheters with SOLO2 Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: February 27, 2018 Received: March 1, 2018

Dear Bryan 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.

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 803); good

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K180548

#### Device Name

PowerPICC Provena Catheters with SOLO2 Valve Technology

Indications for Use (Describe)

The PowerPICC Provena Catheters with SOLO² Valve Technology 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) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Indications for Use

510(k) Number (if known)

### K180548

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) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:10px">☐</span> 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 [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 K180548

21 CFR 807.92(a)

| | Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) |
|-----------------------|---------------------------|--------------------------------------------------------------------------------------------------|
| | Submitter Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| General<br>Provisions | Contact Person: | Bryan Stone<br>Associate Manager, Regulatory Affairs |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date of Preparation: | April 19, 2018 |
| | Trade Name(s): | PowerPICC Provena Catheters<br>PowerPICC Provena Catheters with SOLO2 Valve Technology |
| Subject Devices | Common Name: | Catheter, Intravascular, Therapeutic, Long-term Greater than 30 days |
| | Classification Name: | Percutaneous, Implanted, Long-term intravascular catheter |
| | Product Code/Regulation: | LJS/21 CFR §880.5970 |
| | Class | 2 |
| | Classification Panel | General Hospital |
| | | Predicate Trade Name: |
| Predicate Devices | Classification Name: | Percutaneous, Implanted, Long-term intravascular catheter |
| | Product Code/Regulation: | LJS/21 CFR §880.5970 |
| | Premarket Notification #: | K162443 (PowerPICC Provena)<br>K162441 (PowerPICC Provena Catheters with SOLO2 Valve Technology) |
| | Manufacturer: | Bard Access Systems, Inc. |
| Reference Device | Reference Trade Name: | PowerPICC SOLO Catheter |
| | Classification Name: | Percutaneous, Implanted, Long-term intravascular catheter |
| | Product Code/Regulation: | LJS/21 CFR §880.5970 |
| | Premarket Notification: | K072230 |
| | Manufacturer: | Bard Access Systems, Inc. |

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| Device<br>Description | The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single use<br>devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use, as<br>clinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure<br>monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters<br>(PICC) and utilize the same placement technique as the predicate device. The SOLO2 versions of the subject devices include<br>a silicone valve on the proximal end.<br>The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing<br>PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard<br>and small patient versions. | | | | | | | | | | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|-------------------------------------------------------------------------------------|--|--|--|--|
| Intended Use | The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are intended for<br>short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. | | | | | | | | | | | |
| Indications For<br>Use | The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for<br>intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring.<br>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 3 mL/sec 4F Dual Lumen 5 mL/sec | | | | |
| | The PowerPICC Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term peripheral access to<br>the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central<br>venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge<br>or larger be used. | | | | | | | | | | | |

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| Technological<br>Characteristics | Technological characteristics of the subject PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO²<br>Valve Technology are substantially equivalent with respect to basic design, function and fundamental scientific technology to<br>those of the cited primary predicate devices.<br><br>Key modifications made to the subject devices when compared to the predicate devices are as follows:<br>• The material formulation of the extension leg has been changed from Polycarbonate Polyurethane to Polyether<br>Polyurethane.<br><br>The following table provides a comparison between the subject and predicate devices. | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| | Attribute | Subject Devices – PowerPICC Provena<br>Catheters and PowerPICC Provena Catheters<br>With SOLO² Valve Technology | | |
| | Owner | Same | | |
| | Classification | Same | | |
| 510(k) Status | Subjects of this Premarket Notification | K162443 – Concurrence date October 25, 2016<br>K162441 – Concurrence date April 24, 2017 | | |
| | | | | |
| Indications for Use | Same | 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 | |
| | | 3F Single Lumen | 3 mL/sec | |
| | | 4F Dual Lumen | 5 mL/sec | |
| | | The PowerPICC Provena Catheters with SOLO2 Valve Technology 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 | |
| | | 3F Single Lumen | 3 mL/sec | |
| | | 4F Dual Lumen | 5 mL/sec | |
| Commercial Name | Same | PowerPICC Provena Catheters<br>PowerPICC Provena Catheters with SOLO2 Valve Technology | | |
| Catheter | Same | 3F Single Lumen x 55 cm | | |
| Duration of Use | Same | Short (<30 days) or long-term (>30 days) | | |
| Means of<br>Insertion | Same | Percutaneous using a peel-away sheath<br>Introducer | | |
| Insertion Site | Same | Peripheral | | |
| Primary Device<br>Materials | Catheter Base Materials | Catheter Base Materials | | |
| | Shaft Tubing: | Shaft Tubing: | | |
| | Same | Polycarbonate Polyurethane | | |
| | Luer Connector: | Luer Connector: | | |
| | Same | Polyurethane | | |
| | Extension Legs: | Extension Legs: | | |
| | Polyether Polyurethane | Polycarbonate Polyurethane | | |
| | Junction: | Junction: | | |
| | Same | Polycarbonate Polyurethane (inner)<br>Polyether Polyurethane (outer) | | |
| | Valve (SOLO2 Only): | Valve (SOLO2 Only): | | |
| | Same | Silicone | | |
| Catheter<br>Proximal<br>Configuration | Same | Luer Connection<br>Luer Connection with Valve (SOLO2) | | |
| Catheter Distal<br>Configuration | Same | Open Ended | | |
| Number of<br>Lumens | Same | Single Lumen<br>Dual Lumen | | |
| | Power Injection<br>Maximum Flow Rate | Same | Catheter Size<br>3F Single Lumen | Maximum Flow Rate<br>3 mL/sec |
| | | | 4F Dual Lumen | 5 mL/sec |
| | Sterility | Same | Provided Sterile | |
| | Packaging<br>Configurations | Same | Both Standard and Small Patient versions of the following configurations: Basic Configuration Full Configuration Max Barrier Configuration IR Configuration | |
| | The technological differences listed above were evaluated using the same test requirements as the predicate devices, as defined in the Risk Assessment. Therefore, these differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness. | | | |
| Performance<br>Tests | Based on a risk analysis, the performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. In addition, when technological characteristics between the subject and predicate device were found to be identical, results of the performance testing conducted on the predicate device were applied to the subject device. The following table identifies the performance tests completed on the subject device based upon the specific modification to the extension leg material, including a test description and applicable standard associated with each test. | | | |
| | Verification /<br>Validation Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | | |
| | Assembly Tensile<br>Testing | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements | | |

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| | Dimensional<br>Characterization | Test to demonstrate that the new material formulation conforms correctly to design tolerances of the extension<br>legs.<br>BAS internal standards and procedures |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Leak Decay<br>Testing | Testing performed to evaluate that the catheter assembly will not leak when the distal end of the catheter is<br>occluded.<br>BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular<br>Catheters - Part 1: General requirements |
| | Hydraulic Burst<br>Testing | Testing performed to evaluate that the catheter burst pressure exceeds the peak use pressure at maximum<br>flow conditions.<br>BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular<br>Catheters - Part 1: Genera…