6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER

K093927 · C.R. Bard, Inc. · LJS · Feb 4, 2010 · General Hospital

Device Facts

• Record ID: K093927
• Device Name: 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PowerLine™ catheters are indicated for short or long term access to the central venous system for intravenous therapy and blood sampling.

Device Story

PowerLine™ central venous catheters are open-ended, reverse-taper polyurethane catheters available in 5F dual-lumen and 6F triple-lumen configurations. Designed for short or long-term central venous access, they facilitate IV therapy, blood sampling, parenteral nutrition, and power injection of contrast media. The device features a tissue ingrowth cuff for stabilization, depth markings for insertion reference, and purple colorants to identify power-injectability. Used in clinical settings by healthcare professionals, the catheter allows for central venous pressure monitoring. By providing reliable venous access, the device supports critical care and diagnostic imaging procedures, enabling efficient delivery of fluids and medications while minimizing the need for repeated venipuncture.

Clinical Evidence

Bench testing only. Verification and validation activities were performed on sterilized, finished devices in accordance with ISO 10555-1, ISO 10555-3, and ISO 10993 standards. Design validation confirmed the device met all predetermined performance specifications. No clinical data was required or presented.

Technological Characteristics

Polyurethane catheter; reverse taper design; 5F dual-lumen or 6F triple-lumen configurations; 50 cm usable length; tissue ingrowth cuff; purple colorants for power-injection identification; sterile tray packaging. Standards: ISO 10555-1, ISO 10555-3, ISO 10993-1, ISO 10993-7, ISO 14971.

Indications for Use

Indicated for short or long-term central venous access in patients requiring IV fluid, blood product, drug, or parenteral nutrition administration, blood withdrawal, power injection of contrast media, or central venous pressure monitoring. Recommended lumen size for CVP monitoring is 20 gauge or larger; max infusion rate 5ml/sec.

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

• 5 F Single Lumen (SL) PowerLine™ (K050185)
• 6 F Dual Lumen (DL) PowerLine™ (K051417)
• CVP Monitoring - PICC & CVC (K051991)
• 5F Dual Lumen (DL) PowerPICC™ (K051672)
• 6F Triple Lumen (TL) PowerPICC™ (K053501)

Submission Summary (Full Text)

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Bard Access Systems
PowerLine Central Venous Catheters
Special 510(k) Premarket Notification

K093927
Section 5 – 510(k) Summary

Page 2 of 5

## Section 5

## 510(k) Summary 21 CFR 807.92(a)

FEB - 4 2010

PowerLine™ Central Venous Catheters

| General<br>Provisions | Submitter of 510(k)<br>Premarket Notification: | Bard Access Systems, Inc. (BAS)<br>[Subsidiary of C.R. Bard, Inc.]<br>Salt Lake City, Utah 84116<br>Phone: [phone]<br>Fax: [phone] | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--|
| | Contact Person: | Sarabjyot Mankoo<br>Regulatory Affairs Specialist | | |
| | Device Trade Name:<br>Device Generic Name: | 5 F DL & 6 F TL PowerLine™<br>Central Venous Catheter (CVC) | | |
| Predicate<br>Device | Primary Predicate: | | | |
| | Trade Name: | PowerLine™ | | |
| | Common/Usual Name: | Central Venous Catheter | | |
| | Classification Name: | 80LJS - Long term Intravascular Catheter | | |
| | CFR Reference: | 21 CFR §880.5970- Class II | | |
| | Classification Panel: | General Hospital | | |
| | Premarket Notification: | See table below | | |
| | Secondary Predicate: | | | |
| Trade Name: | PowerPICC™ | | | |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) | | | |
| Classification Name: | 80LJS – Long term Intravascular Catheter | | | |
| CFR Reference: | 21 CFR §880.5970– Class II | | | |
| Classification Panel: | General Hospital | | | |
| Premarket Notification: | See table below | | | |
| | Predicate Device Name | 510(k) | Concurrence Date | |
| | 5 F Single Lumen (SL) PowerLine™ | K050185 | May 26, 2005 | |
| | 6 F Dual Lumen (DL) PowerLine™ | K051417 | June 30, 2005 | |
| | CVP Monitoring - PICC & CVC | K051991 | October 20, 2005 | |
| | 5F Dual Lumen (DL) PowerPICC™ | K051672 | November 23, 2005 | |
| | 6F Triple Lumen (TL) PowerPICC™ | K053501 | January 13, 2006 | |
| Classification | 21 CFR §880.5970- Class II<br>80LJS – Long term Intravascular Catheter | | | |
| Performance<br>Standards | Performance standards have not been established by FDA under section 514<br>of the Federal Food, Drug and Cosmetic Act | | | |

なる。

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| Intended Use | PowerLine™ catheters are indicated for short or long term access to the<br>central venous system for intravenous therapy and blood sampling. |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The PowerLine™ catheter is indicated for short or long term access to the<br>central venous system. PowerLine™ catheters are designed for the<br>administration of I.V. fluids, blood products, drugs, parenteral nutrition<br>solutions, as well as blood withdrawal. In addition, PowerLine™ catheters<br>allow for power injection of contrast media and central venous pressure<br>monitoring. The maximum recommended infusion rate is 5ml/sec. For<br>central venous pressure monitoring, it is recommended that a catheter lumen<br>of 20 gauge or larger be used. |
| Device<br>Description | The PowerLine™ catheters are open-ended polyurethane catheters with a<br>reverse taper design. Catheters are available in 5 F Dual-Lumen and the 6 F<br>Triple-Lumen configurations. The usable length of the catheter is 50 cm.<br>Catheter shaft tubing is marked with depth indicators, with "0" indicated to<br>serve as a reference for the catheter insertion point. The catheters have a<br>tissue ingrowth cuff bonded to the catheter shaft. Purple colorants added to<br>the catheter extension legs and shaft aid in distinguishing the catheter as<br>power-injectable. The molded hub is labeled to identify the catheter as<br>PowerLine™. The catheter extension leg and clamp are labeled with<br>information to facilitate proper use of the device. The PowerLine™ catheters<br>are provided in sterile tray configurations. |
| Technological<br>Characteristics | Technological similarities between the subject PowerLine™ catheters and<br>the predicate device remain identical. There are no new questions raised<br>regarding safety or efficacy of the subject PowerLine™ catheters. |
| Verification &<br>Validation<br>Activities | Verification and validation activities were designed and performed to<br>demonstrate that the subject PowerLine™ catheters met predetermined<br>performance specifications. Tests were performed on sterilized, finished<br>devices. The following guidance documents and standards in conjunction with<br>in-house protocols were used to determine appropriate methods for<br>evaluating the performance of the device:<br>Guidance on Premarket Notification [510(k)] Submission for Short-<br>Term and Long-Term Intravascular Catheters, March 16, 1995 ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1.<br>General requirements, Amendment 2 BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters,<br>Part 3. Central venous catheters AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical<br>Devices Part 1: Evaluation and Testing, and the FDA Modified ISO<br>10993 Test Profile AAMI/ANSI/ISO 10993-7:1995, Biological Evaluation of Medical<br>Devices Part 7: Ethylene Oxide Sterilization Results |
| | The subject PowerLine™ catheters met all predetermined acceptance criteria<br>derived from the above mentioned references. Design validation was<br>conducted on the subject PowerLine™ configuration and yielded acceptable<br>results. |
| | Risk management, including a failure modes and effects analysis (FMEA), of<br>the subject device was conducted in accordance with ISO 14971:2007,<br><i>Medical Devices - Risk Management for Medical Devices</i> . No new types of<br>safety or efficacy questions were identified for the subject PowerLine™<br>catheters. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject PowerLine™ catheters met the minimum<br>requirements for its intended use/indications for use, and is substantially<br>equivalent in design, materials, sterilization, principles of operation and<br>indications for use to current commercially available catheters/cited<br>predicates. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mr. Sarabjyott Mankoo Regulatory Affairs Specialist C. R. Bard, Incorporated Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116

FEB - 4 2010

Re: K093927

Trade/Device Name: PowerLine™ Central Venous Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II

Product Code: LJS Dated: December 17, 2010 Received: January 5, 2010

Dear Mr. Mankoo:

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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## Page 2 - Mr. Mankoo

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Bard Access Systems PowerLine Central Venous Catheters Special 510(k) Premarket Notification Section 4 - Indications for Use Statement

Page 14 of 92

510(k) Number (if known):

Device Name:

PowerLine™ Central Venous Catheters

Indications for Use:

The PowerLine™ catheter is indicated for short or long term access to the central venous system. PowerLine™ catheters are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal. In addition, PowerLine "" catheters allow for power iniection of contrast media and central venous pressure monitoring. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Prescription Use V (Part 21 CFR §801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR §801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093227