POWERHOHN AND POWERLINE CATHETERS

K050185 · C.R. Bard, Inc. · LJS · May 26, 2005 · General Hospital

Device Facts

• Record ID: K050185
• Device Name: POWERHOHN AND POWERLINE CATHETERS
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PowerHohn™ and PowerLine™ Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.

Device Story

PowerHohn and PowerLine are 5 Fr SL open-ended radiopaque polyurethane catheters; reverse taper design; depth indicators on shaft; purple colorant for power injection identification. Used for central venous access; enables administration of fluids/drugs/blood products and power injection of contrast media (max 5cc/sec; max 300 psi). PowerLine includes SureCuff tissue ingrowth cuff; PowerHohn includes optional VitaCuff antimicrobial cuff. Operated by clinicians in clinical settings. Device facilitates venous access and contrast delivery; benefits patient by providing reliable, power-injectable central access.

Clinical Evidence

Bench testing only. Verification testing performed according to FDA guidance for short-term and long-term intravascular catheters and ISO 10555 standards. No clinical data presented.

Technological Characteristics

Radiopaque polyurethane catheter; 5 Fr SL; 50 cm length; reverse taper design. Features purple colorant for identification. Includes SureCuff tissue ingrowth cuff (PowerLine) or optional VitaCuff antimicrobial cuff (PowerHohn). Sterile tray configuration. No new materials used; biocompatibility established via predicate history.

Indications for Use

Indicated for patients requiring short or long-term central venous access for administration of IV fluids, blood products, drugs, parenteral nutrition, blood withdrawal, and power injection of contrast media.

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™ Catheter (K033389)
• Broviac® Catheter (K830256)

Submission Summary (Full Text)

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# MAY 2 6 2005

# 510(k) Summary of Safety and Effectiveness Information

# 5 Fr SL PowerHohn™ and PowerLine™ Catheters

#### Submitter Information 6.1

| Submitter Name: | Bard Access Systems, Inc. (BAS)<br>[Subsidiary of C. R. Bard, Inc.] |
|----------------------|---------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive<br>Salt Lake City, UT 84116 |
| Telephone Number: | [phone], Ext. 5541 |
| Fax Number: | [phone] |
| Contact Person: | Charles Morreale |
| Date of Preparation: | January 17, 2005 |

#### Device Name 6.2

| Device Name: | PowerHohn™ and PowerLine™ Catheter |
|-----------------------|-----------------------------------------------------|
| Trade Name: | PowerHohn™ and PowerLine™ Catheter |
| Common/Usual Name: | Central Venous Catheter |
| Classification Name: | Class II, 80 LJS - Long Term Intravascular Catheter |
| Classification Panel: | General Hospital |

#### Predicate Device(s): 6.3

Device Name: Trade Name: Common/Usual Name: Classification Name: Classification Panel: Premarket Notification:

Device Name: Trade Name: Common/Usual Name: Classification Name: Classification Panel: Premarket Notification: PowerPICC™ Catheter PowerPICCTM Catheter Peripherally Inserted Central Catheter (PICC) Class II, 80 LJS - Long Term Intravascular Catheter General Hospital K033389, Substantial Equivalence: April 14, 2004

Broviac® Catheter Broviac® Catheter Central Venous Catheter Class II, 80 LJS - Long Term Intravascular Catheter General Hospital K830256, Substantial Equivalence: March 1, 1983

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K050185

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#### 6.4 Device Description

- The PowerHohn and PowerLine Catheters are open-ended radiopaque polyurethane . catheters.
- Catheter size is 5 Fr SL with 50 cm usable length. .
- 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.
- PowerHohn and PowerLine Catheters are provided in sterile tray configurations. .
- Purple colorants were added to the catheter materials to provide the catheter with an ● I urpic colorants were added to arer to differentiate the PowerHohn and PowerLine as power injectable from other central venous catheters.
- The molded hub is labeled to identify the catheter as PowerHohn and PowerLine. .
- The catheter extension leg and clamp are labeled with information to facilitate proper use of . the device.

#### Intended Use 6.5

PowerHohn™ and PowerLine™ Catheters are indicated for short or long term access to the central I owcirrom - and rower hasigned for administering I.V. fluids, blood products, drugs and parenteral venous system. "They are designed withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.

#### Technological Characteristics Summary 6.6

New device is compared to Marketed Device

Yes.

### Does the new device have the same indication statement?

Yes. However, the Indications For Use were expanded to provide instructions for chest placement, percutaneous introduction and tunneling techniques for central venous catheters.

### Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)?

No, the differences do not alter the intended use of the device.

### Does the new device have the same technological characteristics, e.g. design, material, etc.?

Yes. The PowerHohn and PowerLine catheters are identical to the PowerPICC catheter in terms of catheter design, materials, color (purple), and manufacture, with the exception of the addition of a SureCuff® Tissue Ingrowth Cuff to the PowerLine Catheter and an optional VitaCuff® Antimicrobial Cuff to the PowerHohn Catheter. The basic fundamental scientific technology of the catheter has not changed.

#### Could the new characteristics affect safety or effectiveness?

Yes. The new characteristics could affect safety or effectiveness of the device.

### Do the new characteristics raise new types of safety and effectiveness questions?

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No. There are no new types of safety and effectiveness questions.

# Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and I cs. The I Drive Catheters, dated 3/16/95, and relevant ISO 10555 Standards were used toong Term Intrasterning the methods for evaluating the modified device's performance.

There are no new materials therefore, no new biocompatibility is required.

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

Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.

#### Do performance data demonstrate equivalence?

Yes. Performance data gathered in design verification testing demonstrated that the PowerHohn and PowerLine Catheter is substantially equivalent to the predicate devices.

#### Conclusion

The PowerHohn and PowerLine Catheters met all the predetermined performance criteria of design verification evaluations and is substantially equivalent to the predicate devices.

#### 6.7 Conclusion

The PowerHohn and PowerLine Catheters meet all the acceptance criteria of the testing performed and, based on FDA 's decision tree, is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

MAY 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles Morreale Senior Manager Quality Systems/ Regulatory Affairs Bard Access Systems, Incorporated 5425 West Ameila Earhart Drive Salt Lake City, Utah 84116

Re: K050185

Trade/Device Name: 5 Fr SL PowerHohn and PowerLine Catheters Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 1, 2005 Received: April 8, 2005

Dear Mr. Morreale:

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.

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Page 2 - Mr. Morreale

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 your 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 yours.

Sydette J. Michailoms.

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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K050185

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### PowerHohn™ and PowerLine™ Catheters 510(k) Premarket Notification

### STATEMENT OF INDICATION FOR USE

510(k) Number (if known): K050185

### Device Name: 5 Fr SL PowerHohn and PowerLine Catheters

Indications For Use:

PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm for MW

wision Sign-Off) Mislon Sign-Off)
Wision of Anesthesiology, General Hospital, Intection Control, Dental Devices

2(k) Number: KCSC183