PowerPICC Provena Catheters with SOLO Valve Technology

K162441 · C.R. Bard, Inc. · LJS · Apr 24, 2017 · General Hospital

Device Facts

• Record ID: K162441
• Device Name: PowerPICC Provena Catheters with SOLO Valve Technology
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Apr 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPICC Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term use when clinically indicated and for 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.

Device Story

PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single-use, peripherally inserted central catheters (PICC). Devices feature radiopaque polyurethane shafts with reverse taper design, depth indicators, and proximal silicone valves. Used in clinical settings (IR, nursing) for vascular access; enables intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. Clinicians insert catheters percutaneously using peel-away sheath introducers. Proximal valve technology is identical to reference device (K072230). Output is vascular access; healthcare providers use device to deliver fluids/medications or monitor pressure. Benefits include reliable central venous access with power injection capability and valve-integrated proximal end.

Clinical Evidence

Bench testing only. Testing included mechanical hemolysis, dimensional analysis, catheter collapse under vacuum, luer-to-extension leg tensile strength, priming volume, pump flow, and gravity flow. All tests met predetermined acceptance criteria based on ISO 10555-1:2013 and FDA guidance for intravascular catheters.

Technological Characteristics

Radiopaque polyurethane shaft; silicone proximal valve; polycarbonate/polyurethane luer connector and extension legs. Reverse taper design. Sterile, single-use. Dimensions: 3F (single lumen) and 4F (dual lumen). Complies with ISO 10555-1:2013. No software or electronic components.

Indications for Use

Indicated for patients requiring 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 Provena Catheter (K162443)

Reference Devices

• PowerPICC SOLO Catheter (K072230)

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

April 24, 2017

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

Re: K162441

Trade/Device Name: 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: March 15, 2017 Received: March 17, 2017

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.

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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)

K162441

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) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:100%;">☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size:100%;">☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(k) Summary: K162441 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>Associate Manager, Regulatory Affairs |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date of Preparation: | April 17, 2017 |
| Subject Device | Trade Name(s): | PowerPICC Provena Catheters with SOLO² Valve<br>Technology |
| | Common Name: | Peripherally Inserted Central Catheter (PICC) |
| | Classification Name: | percutaneous, implanted, long-term intravascular<br>catheter |
| | Product<br>Code/Regulation/Class: | LJS/21 CFR §880.5970/Class II |
| Predicate<br>Device | Predicate Trade Name: | PowerPICC Provena Catheter |
| | Classification Name: | percutaneous, implanted, long-term intravascular<br>catheter |
| | Product<br>Code/Regulation/Class: | LJS/21 CFR §880.5970/Class II |
| | Premarket Notification: | K162443 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Reference<br>Device | Reference Trade Name: | PowerPICC SOLO Catheter |
| | Classification Name: | percutaneous, implanted, long-term intravascular<br>catheter |
| | Product<br>Code/Regulation/Class: | LJS/21 CFR §880.5970/Class II |
| | Premarket Notification: | K072230 |
| | Manufacturer: | Bard Access Systems, Inc. |

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| | Bard Access Systems, Inc.'s PowerPICC Provena Catheters with SOLO Valve<br>Technology are sterile, single use devices designed to provide access to the patient's<br>vascular system. The devices are intended for long or short-term use, as clinically<br>indicated, to sample blood and administer fluids intravenously. The catheters are<br>capable of central venous pressure monitoring, and can withstand power injection of<br>contrast media. The catheters are peripherally inserted central catheters (PICC) and<br>utilize the same placement technique as the predicate device. The subject devices<br>include a silicone valve on the proximal end.<br>The subject devices included in this notification are of varying French size and catheter | | | |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--|--|
| | configuration types, as summarized in the table below. | | | |
| | Summary of Subject Devices | | | |
| | Catheter Configuration | French size (Number of Lumens) | | |
| | PowerPICC Provena Catheters | 3 French Single Lumen (SL) | | |
| | with SOLO² Valve Technology | 4 French Dual Lumen (DL) | | |
| Device | The following device descriptors apply to all French sizes and configurations of the<br>subject catheters: | | | |
| Description | Catheters are open-ended, radiopaque polyurethane;<br>● | | | |
| | Catheters incorporate a silicone valve on the proximal end;<br>● | | | |
| | Catheters have a reverse taper design;<br>● | | | |
| | 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<br>●<br>with an appearance that allows the end user to differentiate Bard's power<br>injectable catheters from other manufacturers' power injectable catheters; | | | |
| | Catheter extension legs, luer hubs, and junction are printed with markings to<br>●<br>identify the catheter as PowerPICC Provena Catheters with SOLO- Valve<br>Technology, and include information to facilitate proper use of the device. | | | |
| | The subject devices are provided sterile in basic interventional radiology (IR) kits, as<br>well as basic, full, and max barrier nursing PICC kits with legally marketed components<br>to assist in the placement procedure. These kits are available in both standard and small<br>patient versions. | | | |
| Intended Use | The PowerPICC Provena Catheters with SOLO~ Valve Technology are intended for<br>short- or long-term peripheral access to the central venous system for intravenous<br>therapy and blood sampling. | | | |

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| Indications For | The PowerPICC Provena Catheters with SOLO~ Valve Technology are indicated for<br>short or long-term use when clinically indicated and for peripheral access to the central<br>venous system for intravenous therapy, blood sampling, power injection of contrast<br>media, and allows for central venous pressure monitoring. For central venous pressure<br>monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | | | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-------------------|--|
| Use | | Catheter Size | Maximum Flow Rate | |
| | | 3F Single Lumen | 3 mL/sec | |
| | | 4F Dual Lumen | 5 mL/sec | |
| | | | | |

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Technological characteristics of the subject Povena Catheters with SOLO Valve Technology are substantially equivalent with respect to basic design and function to those of the cited primary predicate device.

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

- The luer hub of the subject catheters has been modified by adding a proximal valve is identical to the valve used in the ● reference device - the PowerPICC SOLO Catheter, K072230.
- Labeling and packaging modifications due to the commercial name change have been made. .

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

| | Subject and Predicate Device Comparison Table | | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| | Attribute | Subject Device - PowerPICC Provena<br>Catheter With SOLO2 Valve<br>Technology | Predicate Device - PowerPICC<br>Provena Catheters (K162443) | Reference Device - PowerPICC SOLO<br>Catheters (K072230) |
| Technological<br>Characteristics | Owner | Same | Bard Access Systems, Inc. | Bard Access Systems, Inc. |
| | Classification | Same | LJS - 21 CFR 880.5970 – Long-Term -<br>Intravascular Catheter | LJS - 21 CFR 880.5970 – Long-Term -<br>Intravascular Catheter |
| | 510(k) Status | Subject of this Premarket Notification | K162443 – Concurrence date October 25,<br>2016 | K072230 - Concurrence date<br>October 05, 2007 |
| Attribute | Subject Device – PowerPICC Provena<br>Catheter With SOLO2 Valve<br>Technology | Predicate Device – PowerPICC<br>Provena Catheters (K162443) | Reference Device – PowerPICC SOLO<br>Catheters (K072230) | |
| Indications for<br>Use | The PowerPICC Provena Catheters with<br>SOLO2 Valve Technology are indicated<br>for short or long-term use when clinically<br>indicated and for peripheral access to the<br>central venous system for intravenous<br>therapy, blood sampling, power injection<br>of contrast media, and allows for central<br>venous pressure monitoring. For central<br>venous pressure monitoring, it is<br>recommended that a catheter lumen of 20<br>gauge or larger be used. | The PowerPICC Provena Catheters are<br>indicated for short or long-term peripheral<br>access to the central venous system for<br>intravenous therapy, blood sampling,<br>power injection of contrast media, and<br>allows for central venous pressure<br>monitoring. For central venous pressure<br>monitoring, it is recommended that a<br>catheter lumen of 20 gauge or larger be<br>used. | The PowerPICC SOLO catheters are<br>indicated for short- or long-term peripheral<br>access to the central venous system for<br>intravenous therapy, power injection of<br>contrast media, and allows for central<br>venous pressure monitoring. For blood<br>sampling, infusion, or therapy, use a 4F or<br>larger catheter. The maximum<br>recommended infusion rate is 5mL/sec for<br>power injection of contrast media. For<br>central venous pressure monitoring, it is<br>recommended that a catheter lumen of 20<br>gauge or larger be used. | |
| | Catheter Size<br>Maximum Flow Rate<br>3F Single Lumen 3 mL/sec<br>4F Dual Lumen 5 mL/sec | Catheter Size<br>Maximum Flow Rate<br>3F Single Lumen 3 mL/sec<br>4F Dual Lumen 5 mL/sec | | |
| Commercial<br>Name | PowerPICC Provena Catheters with<br>SOLO2 Valve Technology | PowerPICC Provena Catheters | PowerPICC SOLO Catheter | |
| Catheter<br>Dimensions | Same as Predicate | 3F Single Lumen x 55 cm<br>4F Dual Lumen x 55 cm | 4F Single Lumen x 55 cm<br>5F Dual Lumen x 55 cm | |
| Duration of<br>Use | Same | Short (<30 days) or long-term<br>(>30 days) | Short (<30 days) or long-term<br>(>30 days) | |
| Subject and Predicate Device Comparison Table | | | | |
| Attribute | Subject Device - PowerPICC Provena<br>Catheter With SOLO2 Valve Technology | Predicate Device - PowerPICC<br>Provena Catheters (K162443) | Reference Device - PowerPICC SOLO<br>Catheters (K072230) | |
| Means of<br>Insertion | Same | Percutaneous using a peel-away sheath<br>Introducer | Percutaneous using a peel-away sheath<br>Introducer | |
| Insertion Site | Same | Peripheral | Peripheral | |
| Primary<br>Device<br>Materials | Catheter Base Materials | Catheter Base Materials | Catheter Base Materials | |
| | Shaft Tubing: | Shaft Tubing: | Shaft Tubing: | |
| | Same as Predicate | Polycarbonate Polyurethane | Polyether Polyurethane | |
| | Luer Connector: | Luer Connector: | Luer Connector: | |
| | Same as Reference | Polyurethane | Polyurethane with Silicone Valve | |
| | Extension Legs: | Extension Legs: | Extension Legs: | |
| | Same as Predicate | Polycarbonate Polyurethane | Polyether Polyurethane | |
| | Junction | Junction: | Junction: | |
| Same as Predicate | Polycarbonate Polyurethane | Polyether Polyurethane | | |
| Catheter<br>Proximal<br>Configuration | Luer Connection with Valve<br>The subject device differs from its primary<br>predicate in terms of the luer hub with valve<br>configuration on the subject device. This<br>difference in the luer does not alter the<br>intended use of the subject device, nor does<br>it raise different questions of equivalence.<br>The luer hub on the subject device is<br>identical to that of the reference device | Luer Connection | Luer Connection with Valve | |

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equivalence.

| Attribute | Subject Device – PowerPICC Provena<br>Catheter With SOLO² Valve Technology | Predicate Device – PowerPICC<br>Provena Catheters (K162443) | Reference Device – PowerPICC SOLO<br>Catheters (K072230) | | | | | | | | | | | | |
|--------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--|--|--|--|--|----------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Catheter Distal<br>Configuration | Same | Open Ended | Open Ended | | | | | | | | | | | | |
| Number of<br>Lumens | Same | Single Lumen<br>Dual Lumen | Single Lumen<br>Dual Lumen | | | | | | | | | | | | |
| Power<br>Injection<br>Maximum Flow<br>Rate | Same as Predicate | Catheter Size Maximum<br>Flow Rate 3F Single Lumen 3 mL/sec 4F Dual Lumen 5 mL/sec | | | | | | | Catheter Size Maximum<br>Flow Rate 4F Single Lumen 5 mL/sec 5F Dual Lumen 5 mL/sec | | | | | | |
| Sterility | Same | Provided Sterile | Provided Sterile | | | | | | | | | | | | |
| Packaging<br>Configurations | Same as Predicate | Both Standard and Small Patient<br>versions of the following configurations:<br>Basic Configuration Full Configuration Max Barrier Configuration IR Configuration | Standard Kits:<br>Basic Configuration Full Configuration Max Barrier Configuration IR Configuration | | | | | | | | | | | | |

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Verification and validation tests were designed and performed in accordance with Design Controls per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establish the performance of the device.

| | Verification /<br>Validation Method | Risk Acceptability Criteria (Acceptance Criteria of Test) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mechanical<br>Hemolysis Test | Testing to determine the hemolytic properties when blood is aspirated<br>through the catheter assembly.<br>• Bard internal standards and procedures |
| | 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.<br>• Bard internal standards and procedures and ISO 10555-<br>1:2013 - Sterile Single-Use Intravascular Catheters - Part 1:<br>General requirements |
| Performance<br>Tests | Catheter Collapse<br>Test | Test to measure the flow rate of aspiration and demonstrate that the<br>catheter will not collapse under a vacuum.<br>• Bard internal standards and procedures and FDA guidance,<br>Guidance on Premarket Notification [510(k)] Submission for<br>Short-Term and Long-Term Intravascular Catheters (March<br>16, 1995) |
| | Luer to Extension<br>Leg Tensile Test | Test to demonstrate the peak tensile force of each test piece exceeds<br>the minimum peak tensile force.<br>• ISO 10555-1:2013 – Sterile Single-Use Intravascular<br>Catheters - Part 1: General requirements |
| | Priming Volume | Test to measure the volume required to prime a full length catheter.<br>• FDA guidance, Guidance on Premarket Notification [510(k)]<br>Submission for Short-Term and Long-Term Intravascular<br>Catheters (March 16, 1995) |
| | Pump Flow | Test to determine the maximum pressure generated by the catheter<br>when infusing water through it at a maximum pump flow rate.<br>• Bard internal standards and procedures |
| | Gravity Flow | Test to measure the gravity flow rate.<br>• Bard internal standards and procedures and FDA guidance,<br>Guidance on Premarket Notification [510(k)] Submission for<br>Short-Term and Long-Term Intravascular Catheters (March<br>16, 1995)<br>• ISO 10555-1:2013 – Sterile Single-Use Intravascular<br>Catheters - Part 1: General requirements |
| | | |
| | The subject devices met all predetermined acceptance criteria derived from the above<br>listed references and demonstrated substantial equivalence as compared to the cited<br>predicate device. | |
| | Risk management, including a failure modes and effects analysis (FMEA), of the subject<br>devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices -<br>Application of Risk Management to Medical Devices. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and results of performance<br>testing, the subject PowerPICC Provena Catheters with SOLO2 Valve Technology meet<br>the requirements that are considered sufficient for its intended use and demonstrate<br>substantial equivalence to the cited predicate device. | |