POWERPICC

K051672 · Bard Access Systems, Inc. · LJS · Nov 23, 2005 · General Hospital

Device Facts

• Record ID: K051672
• Device Name: POWERPICC
• Applicant: Bard Access Systems, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

5 Fr DL PowerPICC is an open-ended, radiopaque polyurethane catheter; reverse taper design; includes depth indicators. Used for peripheral access to central venous system; enables intravenous therapy, blood sampling, and power injection of contrast media. Operated by clinicians in hospital/clinical settings. Purple colorant differentiates from other PICCs. Device provides venous access; power injection capability allows contrast media delivery for imaging procedures. Safety and effectiveness verified via bench testing and FMEA; biocompatibility per ISO 10993.

Clinical Evidence

Bench testing only. Verification and validation testing performed per ISO 10555-1, ISO 10555-3, and FDA guidance for intravascular catheters. Biocompatibility testing per ISO 10993. FMEA used to evaluate risks.

Technological Characteristics

Radiopaque polyurethane catheter; 5 Fr diameter; 55 cm length; reverse taper design. Purple colorant added. Sterile, single-use. Ethylene oxide sterilization. No software or electronic components.

Indications for Use

Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapy, use a 4 French or larger catheter. Max infusion rate 5ml/sec for power injection; max pressure 300 psi.

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

• 6 Fr DL PowerPICC® Catheter (K050931)

Submission Summary (Full Text)

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NOV 2 3 2005

### Section 6

### 510(k) Summary

# 5 Fr DL PowerPICC® Catheter

# 510(k) Summary of Safety and Effectiveness Information 21CFR 807.92

#### 6.1 Submitter Information

| 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. 7136 |
| Fax Number: | [phone] |
| Contact Person: | Lynn M. Kirchoff |
| Date of Preparation: | November 18, 2005 |

#### 6.2 Device Name

| Device Name: | 5 Fr DL PowerPICC® Catheter |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Trade Name: | 5 Fr DL PowerPICC® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Panel: | General Hospital |
| Classification Name: | 80LJS- Long Term Intravascular Catheter<br>21 CFR 880.5970, Class II<br>Peripherally Inserted Central Catheter (PICC) |

#### 6.3 Predicate Device Name(s)

| Device Name: | 6 Fr DL PowerPICC ® Catheter |
|-------------------------|-----------------------------------------------|
| Trade Name: | 6 Fr DL PowerPICC® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K050931, concurrence date-June 15, 2005 |

#### 6.4 Device Description

- The PowerPICC " Catheters are open-ended radiopaque polyurethane catheters. .
- . Catheter size is 5 Fr DI, with 55 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.
- . Catheters are provided sterile in radiology and nursing PICC configurations.
- . Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate the PowerPICC from other PICC catheters.

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- The catheter extension leg, junction and clamp ID tag were printed with markings to identify . the catheter as PowerPICC and to include information to facilitate proper use of the device.
#### Intended Use ર્ણને રાજ્યના સાથે સાથે છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલ

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

The intended use has not changed.

#### 6.6 Indications for Use

The indications for use have not changed from the predicate 6 Fr DL PowerPICC catheter (K050931).

The Power PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. 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. The maximum pressure of power injectors used with the Power PICC catheter may not exceed 300 psi.

#### Summary of Technological Characteristics in Relation to the Predicate Device 6.7

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

Not in all regards. The 5 Fr DL PowerPICC® catheter has some minor differences from the predicate 6 Fr DL PowerPICC® catheter. However, 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?

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

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

Yes. The following FDA guidance documents and international standards were used to evaluate the device's performance:

- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term . Intravascular Catheters, March 16, 1995
- . ISO 10555-1:1997. Sterile, Single-Use Intravascular Catheters, General requirements
- 180 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, . Amendment I
- . ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
- AAMFANSI ISO 11135 1994 Medical Devices -- Falidation and Routine Control of Ethylene ◆ Oxide Steriliation

No new design validation was required. The design validation for the predicate device covered all issues pertaining to the subject device

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Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1 : Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the subject device were previously cleared for similar applications by Bard Access Systems.

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

Yes. Verification and validation testing was performed according to protocols based on the above referenced guidance document recommendations and standards, as well as in accordance with inhouse protocols.

# Do performance data demonstrate equivalence?

Yes. Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

#### Conclusion 6.8

The 5 Fr DL PowerPICC® catheter meets all the predetermined performance acceptance criteria of the testing performed and, based on FDA's decision tree, is substantially equivalent to the predicate device the 6 Fr DL PowerPICC catheter, K050931, concurrence date, June 15, 2005.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2005

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

Re: K051672

Trade/Device Name: 5 Fr DL PowerPICC® Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 18, 2005 Received: November 21, 2005

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.

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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 modifine and regulations and regulations administered by other Federal agencies. of the Act of any I outsal the Act's requirements, including, but not limited to: registration 1 ou intext compry will and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as betrenic 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) I rins reter notification. The FDA finding of substantial equivalence of your device to a promativer now! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you don't 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 maj overnit 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,

Snute H. Michie Davis

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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# Section 1.2

# Indications for Use Statement

510(k) Number (if known):

Device Name: 5 Fr DL PowerPICC® Catheter

Indications For Use:

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mVsec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ching Veno

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എ Anesthesiology, General Hospital, lion Control, Dental Devices

Number: K451672

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