6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC

K043502 · C.R. Bard, Inc. · LJS · Jan 14, 2005 · General Hospital

Device Facts

• Record ID: K043502
• Device Name: 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
• Applicant: C.R. Bard, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Indications for Use

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

Device Story

6 Fr Poly Per-Q-Cath®3 Triple Lumen PICC serves as a conduit for fluids and blood into and out of the central venous system. Device provides peripheral access for intravenous therapy and blood sampling. Operated by clinicians in a clinical setting. Functions as a mechanical conduit; no electronic or software components. Benefits patient by providing reliable, long-term central venous access for therapy and sampling.

Clinical Evidence

Bench testing only. Verification and validation testing performed per FDA guidance and ISO standards (ISO 10555-1, ISO 10555-3, ISO 10993). Biocompatibility testing confirmed materials are safe for long-term, blood-contacting use.

Technological Characteristics

6 Fr triple lumen PICC catheter. Materials previously cleared by Bard Access Systems. Complies with ISO 10555-1 and ISO 10555-3 for intravascular catheters. Sterilized via Ethylene Oxide per AAMI/ANSI/ISO 11135. Mechanical device; 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 blood sampling in patients requiring such access. For blood therapy, use of a 4 French or larger catheter is 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 Catheter (K034019)

Submission Summary (Full Text)

{0}------------------------------------------------

6 Fr Poly Per-

# Section 6

### 510(k) Summary

### 6 Fr Poly Per-Q-Cath 83 Triple Lumen PICC

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

#### 6.1 Submitter Information

| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|----------------------|---------------------------------|
| | [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: | I... M. Kimhoff |
| Date of Preparation: | 16 December, 2004 |

#### 6.2 Device Name

| Device Name: | Poly Per-Q-Cath®3 Triple Lumen PICC Catheter |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Poly Per-Q-Cath®3 Triple Lumen PICC 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

| Device Name: | Poly Per-Q-Cath® PICC Catheter |
|-------------------------|-----------------------------------------------|
| Trade Name: | Poly Per-Q-Cath® PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Long Term Intravascular Catheter (80 LJS) |
| Premarket Notification: | K034019, concurrence date -- January 21, 2004 |

#### 6.4 Device Description

### Principle of Operation

There are no new operating principles. The modified 6 Fr Poly Per-Q-Cath® TL PICC catheter relies on the same basic, fundamental scientific technology as the predicate 6 Fr DL Poly Per-Q Cath PICC. The devices serve as conduit for fluids and blood into. and out of the centry venous system.

#### 6.5 Intended Use

The Triple Lumen PICC is 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.

#### Indications for Use 6.6

{1}------------------------------------------------

The indications for use have not changed from the predicate Poly Per-Q-Cath PICC (K034019).

The Poly Per-Q-Cath® Triple Lumen 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.

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

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

Not in all regards. The 6 Fr Poly Per-Q-Cath® TL PICC has some minor differences from the predicate 6 Fr DI. Poly Per-Q-Cath PICC. However, the basic fundamental scientific technology of the catheter has not changed.

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

ires. The new characteristics could affect safety or effectiveness of the davice,

# 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 .
- ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, . Amendment |
- . ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
- AAMI/ANSI/ISO 11135:1994, Medical Devices -- Validation and Routine Control of Ethylene . Oxide Sterilization

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

Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-J : 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 and validation testing demonstrated that the 6 Fr Poly Per-Q-Cath® TL PICC is substantially equivalent to the predicate 6 Fr DL Poly Per-Q-

Image /page/1/Picture/23 description: The image shows the number 000034. The number is written in a bold, sans-serif font. The numbers are all the same size and are evenly spaced. The background of the image is white.

{2}------------------------------------------------

KC4 3562

6 Fr Poly Per-Q-Cath 53 TL PIC Special 510(k)

Cath PICC, and the risks associated with use of the new device were found acceptable when evaluated by FMFA.

#### Conclusion 6.8

The 6 Fr Poly Per-Q-Cath** TI. PICC meets all the predetermined performance acceptance criteria of the testing performed and, based on FDA's decision tree, is substantially equivalement the predicate device 6 Fr DL Poly Per-Q-Cath PICC, K034019, cleared January quivalen

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, represented by three stylized lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2005

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

Re: K043502

Trade/Device Name: 6 Fr Poly Per-Q-Cath®3 Triple Lumen PICC Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 17, 2004 Received: December 20, 2004

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.

{4}------------------------------------------------

Page 2 - Ms. Kirchoff

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be auvisod that I DIT of issuaires on that your device complies with other requirements Incall that I DX mas made a astes and regulations administered by other Federal agencies. of the Act of ally I oderal base species and systements, including, but not limited to: registration 1 ou mast comply with and the rise ling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quarty is a 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) Fins letter will anow Jourse of Substantial equivalence of your device to a premarket notification. - The PDF 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), If you desire specific advice to: Joan ee 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 may obtain 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,

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

{5}------------------------------------------------

K04350d

..............................................................................................................................................................................

# Indications for Use

510(k) Number (if known):

Device Name: __ 6 Fr Poly Per-Q-Cath®3-Triple Lumen PICC_

Indications for Use:

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

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)

Anthony V. nutz

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

510(k) Number __ kg 4 35 42