POLY PER-Q-CATH PICC CATHETERS

K034019 · C.R. Bard, Inc. · LJS · Jan 21, 2004 · General Hospital

Device Facts

• Record ID: K034019
• Device Name: POLY PER-Q-CATH PICC CATHETERS
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified Poly Per-Q-Cath PICC catheter is intended for short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Device Story

Poly Per-Q-Cath PICC is an open-ended, radiopaque polyurethane catheter designed for peripheral insertion to access the central venous system. Features include a reverse taper design, depth indicators for insertion reference, and extension legs with thumb clamps. Available in various sizes (3, 4, 5 Fr SL and 5, 6 Fr DL) with 60 cm usable length. Used by clinicians for intravenous therapy and blood sampling. Device functions as a conduit for fluid delivery or withdrawal; no electronic or software components. Performance verified through bench testing and FMEA to ensure substantial equivalence to predicate.

Clinical Evidence

Bench testing only. Verification testing performed per FDA guidance for intravascular catheters and ISO standards. Biocompatibility testing conducted per ISO-10993. FMEA used to evaluate risks. All performance criteria met.

Technological Characteristics

Radiopaque polyurethane catheter; reverse taper design; 3, 4, 5 Fr SL and 5, 6 Fr DL sizes; 60 cm length; 2.2 in extension legs with thumb clamps; depth indicators. Biocompatibility per ISO-10993. Sterile.

Indications for Use

Indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, use of 4 French or larger catheter recommended.

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 (K031129)

Submission Summary (Full Text)

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K034019

JAN 2 1 2004

Poly Per-Q-Cath PIC Special 510(k)

### Section 6

### 510(k) Summary 6 Fr DL Poly Per-Q-Cath® PICC Catheters

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

| 6.1 | Submitter Information: | |
|-----|------------------------|------------------------------------------------------------------|
| | Submitter Name: | Bard Access Systems, Inc. |
| | | [Subsidiary of C. R. Bard, Inc.] |
| | Address: | 5425 W. Amelia Earhart Drive |
| | | Salt Lake City, UT 84116 |
| | Telephone Number: | [phone], Ext. 4903 |
| | Fax Number: | [phone] |
| | Contact Person: | Michaela Rivkowich |
| | Date of Preparation: | December 23, 2003 |
| 6.2 | Device Name: | |
| | Device Name: | Poly Per-Q-Cath PICC (Peripherally Inserted Central<br>Catheter) |
| | Trade Name: | Poly Per-Q-Cath PICC Catheter |
| | Common/Usual Name: | Poly Per-Q-Cath PICC |
| | Classification Name: | Long Term Intravascular Catheter (80LJS) |
| 6.3 | Predicate Device: | |
| | Device Name: | Poly Per-Q-Cath PICC (Peripherally Inserted Central<br>Catheter) |
| | Trade Name: | Poly Per-Q-Cath PICC Catheter |
| | Common/Usual Name: | Poly Per-Q-Cath PICC |

#### 6.4 Device Description

Classification Name:

Premarket Notification:

- . The Poly Per-Q-Cath PICC Catheters are open-ended radiopaque polyurethanc catheters.
Long Term Intravascular Catheter (801 JS)

K031129, cleared for marketing on May 5, 2003

- . Catheter sizes are3, 4, 5 Fr SL and 5, 6 Fr DL with 60 cm usable length.
- . The catheter has a reverse taper design.
- . The catheter extension legs are polyurethane extrusions. Extension legs are 2.2 in. in length and cach leg has a thumb clamp.
- . Catheter 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, intermediate and RadPICC kit configurations.

#### 6.5 Intended Use

The modified Poly Per-Q-Cath PICC catheter is intended for short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

#### 6.6 Summary of Technological Characteristics in Relation to Predicate Device:

Does the new device have the same indication statement?

Yes.

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

Not in all regards. There are some minor differences between the predicate and the subject devices. However, the basic fundamental scientific technology of the catheters has not changed.

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

Yes. The changes could affect safety and effectiveness of the device.

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

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

#### 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 Long-Term Intravascular Catheters, dated 3/16/95, and relevant ISO Standards were used to determine the appropriate methods for evaluating the modified device's performance.

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.

## 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 standards, as well as in accordance with in-house protocols. The modified device met the acceptance criteria for the tests performed.

#### Do performance data demonstrate equivalence?

Yes. Performance data demonstrated that the modified Poly Per-Q-Cath PICC is substantially equivalent to the predicate device, and the risks associated with the use of the new device were found acceptable when evaluated by FMEA.

#### 6.7 Conclusion

The modified Poly Per-Q-Cath PICC met predetermined performance acceptance criteria of testing performed and is substantially equivalent to the predicate Poly Per-Q-Cath PICC catheter, cleared under K031129.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

Mr. Michael Rivkowich Senior Regulatory Affairs Specialist Bard Access System, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K034019

Trade/Device Name: Poly Per-Q-Cath PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 23, 2003 Received: December 24, 2003

Dear Mr. Rivkowich:

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. Rivkowich

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 (OS) 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/dsma/dsmamain.html

Sincerely yours.

Chris Ligon Pitts

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 1.2

# INDICATION(S) FOR USE STATEMENT*

The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.

Signature of 510(k) Submitter:

Printed Name of Submitter:

Michaele Peacock

Michaela Rivkowich Sr. Regulatory Affairs Specialist

12/22/03

Date:

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

Concurrence of Office of Device Evaluation

510(k) Number

Ka34019

Division Sign-Off Office of Device Evaluation

Prescription Use

Over-The-Counter Use

Viole Hilbrand Interim Bureau Chief

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental

OR

510(k) Number. K034019

000006