POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC

K031129 · C.R. Bard, Inc. · LJS · May 5, 2003 · General Hospital

Device Facts

• Record ID: K031129
• Device Name: POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: May 5, 2003
• 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 catheters are 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. The device is used for intravenous therapy and blood sampling. Modifications include a change in the durometer of the extension leg material to improve durability and alcohol resistance. The catheter is provided sterile in various configurations (basic, intermediate, RadPICC). It is intended for use by healthcare professionals in clinical settings.

Clinical Evidence

Bench testing only. Verification and validation testing performed according to FDA guidance and ISO standards. Biocompatibility testing conducted per ISO 10993. FMEA analysis performed to evaluate risks.

Technological Characteristics

Radiopaque polyurethane catheter; reverse taper design; 3, 4, 5 Fr (SL) and 4, 5, 6 Fr (DL) sizes; 60 cm length. Extension legs feature modified durometer material for durability/alcohol resistance. Sterile. Complies with ISO 10555 and ISO 10993 standards.

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, 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 (K012902)

Submission Summary (Full Text)

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K03//29

Poly Per-Q-Cath PICC 510(k)

Modifications

#### Section 6

# 510(k) Summary Poly Per-Q-Cath PICC Catheters

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

| 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: | Peggy Keiffer |
| | Date of Preparation: | April 4, 2003 |
| 2. | Device Name: | |
| | Device Name: | Poly Per-Q-Cath PICC (Peripherally Inserted Central Venous<br>Catheter) |
| | Trade Name: | Poly Per-Q-Cath PICC Catheter |
| | | Poly RadPICC |
| | Common/Usual Name: | Poly Per-Q-Cath PICC |
| | Classification Name: | Long Term Intravascular Catheter (80LJS) |
| 3. | Predicate Device: | |
| | Device Name: | Poly Per-Q-Cath PICC (Peripherally Inserted Central Venous |
| | | Catheter) |
| | Trade Name: | Poly Per-Q-Cath PICC Catheter |
| | Common/Usual Name: | Poly Per-Q-Cath PICC |
| | Classification Name: | Long Term Intravascular Catheter (80LJS) |
| | Premarket Notification: | K012902, cleared for marketing on September 10, 2001 |
| 4. | Device Description | |

- The Poly Per-Q-Cath PICC Catheters are open-ended radiopaque polyurethane catheters .
- . Catheter sizes are 3, 4, 5 Fr SL and 4, 5, 6 Fr DL. All are 60 cm usable length
- The catheter has a reverse taper design.
- . The catheter extension legs provide for improved durability and resistance to alcohol and have 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 configurations ..
- ડ. Intended Use

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

#### Summary of Technological Characteristics in relation to Predicate Device: 6.

Does the new device have the same indication statement?

Yes.

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KC3il29

Poly Per-O-Cath PICC 510(k) Modifications

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

Yes, except the durometer of the extension leg material was changed for improved durability and resistance to alcohol

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

Yes. The durometer of the extension leg material 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. Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.

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 10555 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 and validation 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 devices met the acceptance criteria for the tests performed.

#### Do performance data demonstrate equivalence?

Yes. Performance data demonstrated that the modified Poly Per-Q-Cath PICCs are substantially equivalent to the predicate devices and/ or met pre-determined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

#### 7. Conclusion

The modified Poly Per-Q-Cath PICCs met predetermined performance acceptance criteria of testing performed and are substantially equivalent to the predicate Poly Per-Q-Cath PICC catheters, cleared under K012902.

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MAY - 5 2903

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Peggy Keiffer Senior Regulatory Affairs Manager C. R. Bard, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K031129

Trade/Device Name: Poly Per-Q-Cath PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJS Dated: April 4, 2003 Received: April 9, 2003

Dear Ms. Keiffer:

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. Keiffer

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/dsma/dsmamain.html

Sincerely yours,

Susan Rhodes

Susan Runner, DDS, MA Interim 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.

The Poly RadPICC 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:

Buzzy Kriff

Peggy Keiffer Sr. Regulatory Affairs Manager

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

K031129

Division Sign-Off Office of Device Evaluation

Prescription Use

OR Over-The-Counter Use

Patricio Cussiante

siology. General Hospital,

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