POWERPICC SV CATHETERS

K102159 · C.R. Bard, Inc. · LJS · Nov 17, 2010 · General Hospital

Device Facts

• Record ID: K102159
• Device Name: POWERPICC SV CATHETERS
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Nov 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPICC® SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Device Story

PowerPICC® SV catheter is a peripherally inserted central catheter (PICC) designed for power injection of contrast media, intravenous therapy, blood sampling, and central venous pressure monitoring. Available in 3F single lumen and 4F dual lumen configurations. Device is inserted peripherally to access the central venous system. Catheter extension leg, luer hub, and junction feature printed markings to facilitate proper use. Provided in sterile kit configurations. Used by clinicians in clinical settings. Enables power injection of contrast media at specified flow rates (1 mL/sec for 3F; 2.5 mL/sec for 4F). Benefits include reliable central venous access for various therapies and diagnostic procedures.

Clinical Evidence

Bench testing only. Verification and validation activities performed on sterilized, finished devices per ISO 10555-1, ISO 10555-3, and ISO 10993 standards. FMEA conducted per ISO 14971. Results met all predetermined acceptance criteria.

Technological Characteristics

Percutaneous, long-term intravascular catheter. Materials evaluated per ISO 10993. Sterilization via ethylene oxide per ISO 11135. Configurations: 3F single lumen and 4F dual lumen. Features printed markings on extension leg, luer hub, and junction. Power injection capable.

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 20 gauge or larger lumen).

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

• Poly Per-Q-Cath® PICC Catheter (K034019, K051991)
• 6F Triple Lumen Poly Per-Q-Cath® PICC Catheter (K043502, K051991)
• 4F Single Lumen PowerPICC® Catheter (K070996)
• 5F Single Lumen PowerPICC® Catheter (K033389, K051991)
• 6F Triple Lumen PowerPICC® Catheter (K053501, K051991)
• PowerLine® Catheters (K093927)

Reference Devices

• Morpheus® CT PICC Catheter (K072196)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with a unique design where the letters are interconnected. Below "BARD" is the text "ACCESS SYSTEMS" in a smaller, sans-serif font.

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K102159 NOV 1 7 2010

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

## PowerPICC® SV Catheter

| General<br>Provisions | Submitter Name:<br>Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|-----------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Jessica Agnello |
| | Telephone Number:<br>Fax Number:<br>Date of Preparation: | Regulatory Affairs Specialist<br>[phone]<br>[phone]<br>November 4, 2010 |
| Subject<br>Device | Trade Name:<br>Common Name:<br>Classification Name: | PowerPICC® SV Catheter<br>Peripherally Inserted Central Catheter (PICC)<br>Percutaneous, implanted, long-term intravascular<br>catheter<br>LJS, 21 CFR § 880.5970 Class II |
| Predicate<br>Devices | Trade Name:<br>Classification Name: | Poly Per-Q-Cath® PICC Catheter<br>Percutaneous, implanted, long-term intravascular<br>catheter |
| | Premarket Notification:<br>Manufacturer: | LJS, 21 CFR §880.5970 Class II<br>K034019, K051991<br>Bard Access Systems, Inc. |
| | Trade Name:<br>Classification Name: | 6F Triple Lumen Poly Per-Q-Cath® PICC Catheter<br>Percutaneous, implanted, long-term intravascular<br>catheter |
| | Premarket Notification:<br>Manufacturer: | LJS, 21 CFR §880.5970 Class II<br>K043502, K051991<br>Bard Access Systems, Inc. |
| | Trade Name:<br>Classification Name: | 4F Single Lumen PowerPICC® Catheter<br>Percutaneous, implanted, long-term intravascular<br>catheter, |
| | Premarket Notification:<br>Manufacturer: | LJS, 21 CFR §880.5970 Class II<br>K070996<br>Bard Access Systems, Inc |
| | Trade Name:<br>Classification Name: | 5F Single Lumen PowerPICC® Catheter<br>Percutaneous, implanted, long-term intravascular<br>catheter, |
| | Premarket Notification:<br>Manufacturer: | LJS, 21 CFR §880.5970 Class II<br>K033389, K051991<br>Bard Access Systems, Inc |

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| Trade Name: | 6F Triple Lumen PowerPICC® Catheter | | | | | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter,<br>LJS, 21 CFR §880.5970 Class II | | | | | | |
| Premarket Notification: | K053501, K051991 | | | | | | |
| Manufacturer: | Bard Access Systems, Inc | | | | | | |
| Trade Name: | PowerLine® Catheters | | | | | | |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter,<br>LJS, 21 CFR §880.5970 Class II | | | | | | |
| Premarket Notification: | K093927 | | | | | | |
| Manufacturer: | Bard Access Systems, Inc | | | | | | |
| Trade Name: | Morpheus® CT PICC Catheter | | | | | | |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter,<br>LJS, 21 CFR §880.5970 Class II | | | | | | |
| Premarket Notification: | K072196 | | | | | | |
| Manufacturer: | AngioDynamics, Inc | | | | | | |
| Device Description | The subject PowerPICC® SV catheters are members of Bard Access<br>Systems' PowerPICC® series of power injectable catheters. The<br>PowerPICC® SV catheters are available in 3F single lumen and 4F dual<br>lumen configurations. The catheter extension leg, luer hub and junction are<br>printed with description markings to facilitate proper use of the device.<br>The PowerPICC® SV catheters are provided in sterile kit configurations. | | | | | | |
| Intended Use | The PowerPICC® SV catheters are intended for short or long term peripheral<br>access to the central venous system for intravenous therapy and blood<br>sampling. | | | | | | |
| Indications For Use | The PowerPICC® SV catheter is indicated for short or long-term peripheral<br>access to the central venous system for intravenous therapy, blood sampling,<br>power injection of contrast media, and allows for central venous pressure<br>monitoring. For central venous pressure monitoring, it is recommended that a<br>catheter lumen of 20 gauge or larger be used. | | | | | | |
| | Catheter Size Maximum Flow Rate 3 F Single Lumen 1 mL/sec 4 F Dual Lumen 2.5 mL/sec | | | | | | |
| Technological Characteristics | Technological characteristics of the subject PowerPICC® SV catheters are<br>equivalent with respect to the basic catheter design and function to those of<br>the predicate Poly Per-Q-Cath® Catheters. Technical characteristics based<br>on the subject device's power injection capabilities are comparable to the<br>predicate 4F SL PowerPICC® catheter and the Morpheus® CT PICC<br>catheter. Differences do not raise any new questions regarding safety and | | | | | | |

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| Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed to demonstrate that the subject PowerPICC® SV catheters met predetermined performance specifications. Tests were performed on sterilized, finished devices. The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:<br>• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995<br>• ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements<br>• BS/EN/ISO 10555-3:1996/Cor 1:2002, Sterile, single-use intravascular catheters, Part 3. Central venous catheters<br>• AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile<br>• AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results<br>• AAMI/ANSI/ISO 11135:2007, Sterilization of Healthcare Products Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
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| | The subject PowerPICC® SV catheters met all predetermined acceptance criteria derived from the above mentioned references. Design validation was conducted on the subject PowerPICC® SV configuration and yielded acceptable results. |
| | Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2007, Medical Devices - Risk Management for Medical Devices. No new types of safety or efficacy questions were identified for the subject PowerPICC® SV catheters. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerPICC® SV catheters met the minimum requirements for its intended use/indications for use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol composed of three curved lines that resemble a human figure or abstract design. The logo is black and white and appears to be a scanned or printed image.

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

Ms. Jessica Agnello Regulatory Affairs Specialist C.R. Bard, Incorporated 605 North 5600 West Salt Lake City, Utah 84116

NOV . 1 7 2010

Re: K102159

Trade/Device Name: PowerPICC® SV Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 4, 2010 Received: November 5, 2010

Dear Ms. Agnello:

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- Ms. Agnello

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

I. Hata 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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## Indications for Use

NOV 1 7 2010

510(k) Number (if known):

K102159

Device Name:

PowerPICC® SV Catheter

Indications for Use:

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 |
|------------------|-------------------|
| 3 F Single Lumen | 1 mL/sec |
| 4 F Dual Lumen | 2.5 mL/sec |

V Prescription Use (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 IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhd C. Chape 11/17/10

Page 1 of 1 (Division Sinn-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Numbar.

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