POWERPICC SOLO

K072230 · C.R. Bard, Inc. · LJS · Oct 5, 2007 · General Hospital

Device Facts

• Record ID: K072230
• Device Name: POWERPICC SOLO
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

PowerPICC SOLO™ is a clampless, proximally valved, radiopaque polyurethane PICC; available in 4Fr SL, 5Fr SL/DL, 6Fr DL/TL configurations. Device provides peripheral access to central venous system for therapy, power injection of contrast media, and CVP monitoring. Features reverse taper design and depth indicators for insertion reference. Purple colorant and blue luer hub distinguish device as power-injectable. Used in clinical settings by healthcare professionals. Output is venous access; enables infusion, sampling, and pressure monitoring. Benefits include reduced need for multiple sticks and compatibility with power injection protocols.

Clinical Evidence

Bench testing only. Testing conducted per ISO 10555-1, ISO 10555-3, ISO 594-2, and IEC 60601-2-34. Biocompatibility evaluated per ISO 10993. Performance testing confirmed radiopacity (ASTM F640-79), sterilization validation (AAMI/ANSI/ISO 11135), and suitability for invasive blood pressure monitoring (ANSI/AAMI BP22).

Technological Characteristics

Radiopaque polyurethane catheter; clampless, proximally valved design. Reverse taper shaft with depth markings. 4Fr to 6Fr sizes. Luer lock fittings per ISO 594-2. Sterilized via ethylene oxide (AAMI/ANSI/ISO 11135). Compatible with invasive blood pressure monitoring equipment (IEC 60601-2-34).

Indications for Use

Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure (CVP) monitoring. Requires 4 French or larger catheter for blood sampling, infusion, or therapy. Max infusion rate 5ml/sec. CVP monitoring requires 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

• 5 Fr Single Lumen (SL) PowerPICC® catheter (K033389)
• 6 Fr Dual Lumen (DL) PowerPICC® catheter (K050931)
• 5 Fr Dual Lumen (DL) PowerPICC® catheter (K051672)
• 6 Fr Triple Lumen (TL) PowerPICC® catheter (K053501)
• 4 Fr Single Lumen (SL) PowerPICC® catheter (K070996)
• PowerPICC®, Poly Per-Q-Cath, 6 Fr TL Poly Per-Q-Cath, PowerHohn and PowerLines (K051991)
• 5 Fr SL PowerGroshong™ PICC Catheter (K063848)
• Vaxcel® PICC with PASV® Valve Technology (K021704)

Submission Summary (Full Text)

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K072230

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

| OCT 5 | 2007<br>PowerPICC SOLOTM Catheter Family<br>Prepared August 9, 2007 | | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|
| 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], Ext. 7136<br>[phone]<br>Fax: | | |
| | Contact Person: | Lynn M. Kirchoff<br>Regulatory Affairs Specialist | | |
| | Device Trade Name:<br>Device Generic Name: | PowerPICC SOLO™ Catheter<br>Peripherally Inserted Central Catheter (PICC) | | |
| | Trade Name:<br>Common/Usual Name: Peripherally Inserted Central Catheter (PICC)<br>Classification Name:<br>CFR Reference:<br>Classification Panel:<br>Premarket Notification: See below | PowerPICC® Catheter<br>21 CFR §880.5970, Class II<br>General Hospital | 80 LJS- Long Term Intravascular Catheter | |
| | Predicate Device Name | 510(k) | Concurrence Date | |
| | 5 Fr Single Lumen (SL)<br>PowerPICC® catheter | K033389 | March 14, 2004 | |
| Predicate<br>Devices | 6 Fr Dual Lumen (DL)<br>PowerPICC® catheter | K050931 | June 15, 2005 | |
| | 5 Fr Dual Lumen (DL)<br>PowerPICC® catheter | K051672 | November 23, 2005 | |
| | 6 Fr Triple Lumen (TL)<br>PowerPICC® catheter | K053501 | January 13, 2006 | |
| | 4 Fr Single Lumen (SL)<br>PowerPICC® catheter | K070996 | May 8, 2007 | |
| | PowerPICC®, Poly Per-Q-Cath,<br>6 Fr TL Poly Per-Q-Cath,<br>PowerHohn and PowerLines | K051991 | October 20, 2005 | |
| | Trade Name:<br>Common/Usual Name: Peripherally Inserted Central Catheter (PICC)<br>Classification Name:<br>CFR Reference:<br>Classification Panel:<br>Premarket Notification: See below | PowerGroshong™ PICC Catheter<br>21 CFR §880.5970, Class II<br>General Hospital | 80 LJS- Long Term Intravascular Catheter | |
| | Predicate Device Name | 510(k) | Concurrence Date | |
| | 5 Fr SL PowerGroshong™<br>PICC Catheter | K063848 | April 4, 2007 | |

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| Predicate<br>Devices<br>Continued | Trade Name: Vaxcel® PICC with PASV® Valve Technology<br>Common/Usual Name: Peripherally Inserted Central Catheter (PICC)<br>Classification Name: 80 LJS-Long Term Intravascular Catheter<br>CFR Reference: 21 CFR §880.5970, Class II<br>Classification Panel: General Hospital<br>Premarket Notification: See below | K072230<br>Pg2 | | | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--|--|--|--|--|--|
| | Predicate Device Name 510(k) Concurrence Date Vaxcel® PICC with PASV®<br>Valve Technology K021704 June 6, 2002 | | | | | | | |
| Classification | 21 CFR 880.5970, Class II, 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. | | | | | | | |
| Intended Use | The PowerPICC SOLO™ catheters are intended for short or long term<br>peripheral access to the central venous system for intravenous therapy and<br>blood sampling.<br>The intended use has not changed from the predicate PowerPICC® catheters. | | | | | | | |
| Indications for<br>Use | The PowerPICC SOLO™ catheter is indicated for short or long term peripheral<br>access to the central venous system for intravenous therapy, power injection of<br>contrast media and allows for central venous pressure monitoring. For blood<br>sampling, infusion or therapy, use a 4 French or larger catheter. The maximum<br>recommended infusion rate is 5ml/sec. For central venous pressure<br>monitoring, it is recommended that catheter lumen of 20 gauge or larger be<br>used.<br>The indications for use have not changed from the predicate PowerPICC®<br>catheters. | | | | | | | |
| Device<br>Description | The PowerPICC SOLO™ catheter is a clampless proximally valved catheter. The PowerPICC SOLO™ catheters are open-ended radiopaque polyurethane. The PowerPICC SOLO™ catheters are offered in 4 Fr Single Lumen (SL), 5 Fr Single Lumen (SL), 5 Fr Dual Lumen (DL), 6 Fr Dual Lumen (DL), and 6 Fr Triple Lumen (TL) configurations. Catheter usable length is 55 cm. The catheter has a reverse taper design Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point. Catheters are provided sterile in basic and full PICC configurations with legally marketed kit components. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate | | | | | | | |

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Bard Access Systems
PowerPICC SOLO™ Catheter
Special 510(k) Premarket Notification

Section 5 – 510(k) Summary

Page 22 of 112

K072230
Pg3

| Device<br>Description<br>Continued | Bard's power injectable catheters from other manufacturers' catheters.<br>Lower portion of luer hub is blue to identify the catheter as PowerPICC<br>SOLO™ catheter.<br>The catheter extension leg, luer hub and junction were printed with<br>markings to identify the catheter as PowerPICC SOLO™ and to<br>include information to facilitate proper use of the device. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | Technological similarities between the subject PowerPICC SOLO™ catheters<br>and the predicate devices remain identical. There are no new questions raised<br>regarding safety or efficacy of the PowerPICC SOLO™ catheters. |
| Safety and<br>Performance<br>Tests | Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical<br>Devices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test<br>Profile for externally communicating, blood contacting, long-term devices have<br>been met. |
| | Performance testing of the PowerPICC SOLO™ catheters were conducted in<br>accordance with the following FDA guidance documents and international<br>standards: |
| | Guidance on Premarket Notification [510(k)] Submission for Short-<br>Term and Long-Term Intravascular Catheters, March 16, 1995 BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular<br>catheters, Part 1. General requirements ISO 10555-1:2004, Sterile, single-use intravascular catheters, Part<br>1. General requirements, Amendment 2 ASTM F640-79 (reapproved 2000), Standard Test Methods for<br>Radiopacity of Plastics for Medical Use BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular<br>catheters, Part 3. Central venous catheters ISO 594-2: 1998, Conical fittings with a 6% (Luer) taper for<br>syringes, needles and certain other medical equipment - Part 2:<br>Lock Fittings AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and<br>Routine Control of Ethylene Oxide Sterilization 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 IEC 60601-2-34: 2000-10, Medical electrical equipment -<br>Particular requirements for the safety, including essential<br>performance, of invasive blood pressure monitoring equipment AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive<br>Blood Pressure Monitoring ANSI/AAMI BP22: 1994, Blood Pressure Transducers |
| | Subject product testing has yielded acceptable safety & performance<br>outcomes. |
| | The results of these tests, in conjunction with the substantial equivalence<br>claims as outlined in the premarket notification, effectively demonstrate the<br>PowerPICC SOLO™ catheters' substantial equivalence to the cited predicate<br>devices. |

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Bard Access Systems PowerPICC SOLO™ Catheter
Special 510(k) Premarket Notification Section 5 - 510(k) Summary

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K072230
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Summary of Substantial Equivalence

Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerPICC SOLO™ catheters met the minimum requirements that are considered adequate for its intended 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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Image /page/4/Picture/2 description: The image shows the seal for the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

## NOV 18 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynn M. Kirchoff Regulatory Affairs Specialist C.R. Bard, Incorporated Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116

Re: K072230 Trade/Device Name: PowerPICC SOLO™ Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 6, 2007 Received: September 7, 2007

Dear Ms. Kirchoff:

This letter corrects our substantially equivalent letter of October 5, 2007. 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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. Kirchoff

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); 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.

In addition, we have determined that your device kit contains chloraprep applicator, alcohol wipes, and lidocaine 1% which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph. D. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Bard Access Systems PowerPICC SOLO™ Catheter Special 510(k) Premarket Notification Section 4 - Indications for Use Statement

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510(k) Number (if known):

Device Name:

长072230 PowerPICC SOLO™ Catheter Familv

Indications for Use:

The PowerPICC SOLO™ catheter is indicated for short or long term peripheral access . to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that 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)

Signature

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: