POWERGROSHONG PICC CATHETER

K063848 · C.R. Bard, Inc. · LJS · Apr 4, 2007 · General Hospital

Device Facts

• Record ID: K063848
• Device Name: POWERGROSHONG PICC CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Apr 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerGroshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media.

Device Story

5 Fr Single Lumen (SL) PowerGroshong™ PICC is a valved, long-term peripheral access catheter; provides access to central venous system for intravenous therapy and power injection of contrast media. Device consists of silicone catheter with blue and purple colorants for identification. Used by clinicians in clinical settings for patients requiring central venous access. Power injection capability allows for contrast media delivery at rates up to 4 ml/sec. Device functions as a conduit for fluids and contrast; does not involve electronic processing or automated decision-making. Benefits include reliable venous access and compatibility with power injection protocols.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance for intravascular catheters and applicable ISO/ASTM standards (ISO 10555-1/3, ISO 594-2, ASTM F640-79, ISO 10993-1). Results confirmed substantial equivalence to predicate devices.

Technological Characteristics

Silicone catheter with blue/purple colorants; 5 Fr single lumen configuration. Features distal valve. Materials evaluated per ISO 10993-1. Radiopacity per ASTM F640-79. Conical fittings per ISO 594-2. Sterilization via ethylene oxide per AAMI/ANSI/ISO 11135.

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media at a maximum rate of 4 ml/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 Fr DL Groshong® nXt PICC Catheter (K023374)
• 6 Fr TL PowerPICC® Catheter (K053501)

Submission Summary (Full Text)

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K063848

3

PowerGroshong Traditional 510(k)

APR - 4 2007

# Section 5 5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter 510(k) Summary

## 5.1 General Information

| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|----------------------------------|-----------------------------------------------|
| | [Wholly owned Subsidiary of C. R. Bard, Inc.] |
| Address: | 5425 W. Amelia Earhart Drive |
| | Salt Lake City, UT 84116 |
| Telephone Number: | [phone] ext. 7136 |
| Fax Number: | [phone] |
| Contact Person: | Lynn M. Kirchoff |
| Date of Preparation: | December 27, 2006 |
| Registration Number: | 1720496 |
| Additional Registration Numbers: | |
| C.R. Bard: | 2212754 |

# 5.2 Subject Device Information

| Device Name: | 5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter |
|-----------------------|-------------------------------------------------------------------------------------------------|
| Trade Name: | 5 Fr Single Lumen (SL) PowerGroshong™ PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | 80 LJS - Percutaneous, Implanted, Long-Term Intravascular Catheter<br>21 CFR 880.5970- Class II |
| Classification Panel: | General Hospital |

## 5.3 Predicate Device Information

| Device Name(s): | 5 Fr Dual Lumen (DL) Groshong® nXt PICC Catheter |
|-----------------------|-------------------------------------------------------------------------------------------------|
| | 6 Fr Triple Lumen (TL) PowerPICC® Catheter |
| Trade Name(s): | Groshong® nXt, PowerPICC® |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | 80 LJS - Percutaneous, Implanted, Long-Term Intravascular Catheter<br>21 CFR 880.5970- Class II |
| Classification Panel: | General Hospital |

| Predicate Device Name | 510(k) | Clearance Date |
|-------------------------------------|---------|----------------|
| 5 Fr DL Groshong® nXt PICC Catheter | K023374 | 12/18/2002 |
| 6 Fr TL PowerPICC® Catheter | K053501 | 1/13/2006 |

## 5.4 Intended Use

The intended use of the 5 Fr SL PowerGroshong is the same as the intended use of the predicate devices.

The PowerGroshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy, and blood sampling.

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K063848 page 2 of
PowerGroshong™
Traditional 510(k)

### Indications for Use ર્સ્ડ

The Indications for Use for the 5 Fr SL PowerGroshong™ PICC Catheter is as follows:

The PowerGroshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media.

#### Device Description 5.6

The PowerGroshong™ PICC catheters are valved, long-term peripheral access catheters. The catheters are made of silicone material to which a blue and purple colorant have been added. Blue colorants were added to the catheter materials to allow the users to identify the catheter as a Groshong distally valved catheter. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters. The PowerGroshong™ PICC catheters are available in 5 Fr single lumen catheter configuration. The catheters are packaged in basic and full with microintroducer kits that incorporate kit components designed to meet the needs of the respective placer.

#### 5.7 Technological Comparison to Predicate Devices

The technological characteristics of the 5 Fr SL PowerGroshong™ PICC are substantially equivalent to those of the predicate devices in terms of intended use, application, basic design, performance, labeling, packaging and sterilization method.

#### 5.8 510(k) Substantial Equivalence Decision Tree

New device is compared to Marketed Device? Yes.

Does the new device have the same indication statement and intended use as the predicate? Yes. The intended use and indications for use are a combination of the indications from the predicate Groshong® nXt and PowerPICC® catheters 510(k) K023374 and K053501.

Does the new device have the same technological characteristics, e.g. design, materials, etc.? Not in all regards. The principles of operation and basic design are the same as the predicate devices. The main difference is the addition of the power injection to a valved catheter.

# Could the new characteristics affect safety or effectiveness?

Yes. The design changes may affect safety or effectiveness of the device.

Do the new characteristics raise new types of safety and effectiveness questions? No. Safety and effectiveness questions are the same as for the predicate devices.

Do accepted scientific methods exist for assessing effects of the new characteristics? Yes. Testing was performed to assess the new characteristics and was based on the following applicable standards and FDA guidance document:

- o Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95
- BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General O requirements

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- BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General o requirements
- ISO 10555-1:1995, Sterile, single-use intravascular catheters, Part 1. General 0 requirements, Amendment 1:1999
- BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central 0 venous catheters
- ISO 594-2: 1998. Conical fittings with a 6% (Luer) taper for syringes, needles and O certain other medical equipment - Part 2: Lock Fittings
- ASTM F640-79 (reapproved 2000), Standard Test Methods for Radiopacity of Plastics O for Medical Use
- ี AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of o Ethylene Oxide Sterilization
- AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: o Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile

# Are performance data available to assess effects of new characteristics?

Yes. Bench testing was based on the above referenced guidance document and standards. All test results confirm that the subject device is substantially equivalent to the predicate devices.

### 5.9 Conclusion

The 5 Fr SL PowerGroshong™ PICC met all the performance criteria of the tests performed and, based on FDA's decision tree, is substantially equivalent to its predicate devices, the 5 Fr DL Groshong® nXt PICC and the 6 Fr TL PowerPICC® Catheter covered by: K023374 and K053501 respectively.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Access Systems, Incorporated Ms. Lynn M. Kirchoff Regulatory Affairs Specialist 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

APR - 4 2007

Re: K063848

Trade/Device Name: 5 Fr SL PowerGroshong™ PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: March 1, 2007 Received: March 2, 2007

Dear Ms. Kirchoff:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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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); 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.

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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

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

# Enclosure

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# Section 4 Indications for Use

510(k) Number (if known): K063848

Device Name: 5 Fr SL PowerGroshong™ PICC Catheter

Indications for Use:

The Power Groshong™ PICC is intended for short or long-term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. The maximum recommended infusion rate is 4 ml/sec for power injection of contrast media.

Prescription Use X (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)

C

Cari-OW) trion of Anesthesiology, General Hospital, Chacaon Control, Dental Devices

C(k) Number ....