VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING

K992532 · Baxter Healthcare Corp · FOZ · Jun 13, 2000 · General Hospital

Device Facts

• Record ID: K992532
• Device Name: VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
• Applicant: Baxter Healthcare Corp
• Product Code: FOZ · General Hospital
• Decision Date: Jun 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Vantex™ Central Venous Catheter with OLIGON™ with or without AMC™ Thromboshield™ coating are indicated for use in patients requiring pressure monitoring, infusion of solutions, and blood sampling in the central vein. All catheters are manufactured with a polyurethane-based OLIGONTM antimicrobial polymer. The OLIGON™ material uses silver as the antimicrobial agent.

Device Story

Triple lumen central venous catheter; constructed from polyurethane-based Oligon™ antimicrobial polymer containing silver; optional AMC™ Thromboshield™ coating. Features soft, flexible distal tip to reduce vessel perforation risk; includes injection caps, removable slide clamps, and suture loops. Used in clinical settings for pressure monitoring, solution infusion, and blood sampling. Clinicians insert catheter into central vein; radiopacity enhanced via barium sulfate for visualization on chest X-ray. Antimicrobial properties provide ≥ 3 log reduction of common pathogens within 48 hours. Device benefits include reduced infection risk and improved catheter patency.

Clinical Evidence

Clinical study conducted in Canada evaluated safety of silver, platinum, and benzalkonium chloride release from the catheter. Serum and urine levels were monitored before, during, and after use; results showed safe levels of all substances. Marketing evaluation in Europe assessed performance and radiopacity, leading to the addition of barium sulfate to the Oligon™ formulation.

Technological Characteristics

Polyurethane-based Oligon™ antimicrobial polymer (silver-based); optional AMC™ Thromboshield™ coating (benzalkonium chloride). Triple lumen configuration. Includes barium sulfate for radiopacity. Sterilized via 100% ethylene oxide. Complies with ISO 10555-1, ISO 10555-3, and ISO 10993-1 standards.

Indications for Use

Indicated for patients requiring pressure monitoring, infusion of solutions, and blood sampling in the central vein.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Multi-Med Multi-Lumen Central Venous Catheter with AMC™ Thromboshield™
• Arrow International's Central Venous Multi-Lumen Catheter with ARROWgard Blue

Submission Summary (Full Text)

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

| 510(k) Summary, Safety and Effectiveness | 1992532 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Edwards Lifesciences, LLC<br>17221 Red Hill Avenue<br>Irvine, California 92614 USA |
| Contact: | Jason Smith<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | VantexTM Central Venous Catheter with OligonTM<br>material with or without AMCTM ThromboshieldTM<br>coating |
| Common Name: | Central Venous Catheter |
| Classification: | Class II (Reference 21 CFR 880.5200) |
| Predicate or Legally<br>Marketed Device: | Multi-Med Multi-Lumen Central Venous Catheter<br>with AMCTM ThromboshieldTM and Arrow<br>International's Central Venous Multi-Lumen<br>Catheter with ARROWgard Blue |
| Date prepared: | July 27, 1999 |

#### Device Description

The Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ coating is a triple lumen central venous catheter constructed primarily from Oligon™ material. A soft, flexible tip is formed onto the distal tip of the catheter to reduce the potential for vessel perforation. Each lumen is intended for pressure monitoring, solution infusion, and blood sampling. The Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ coating is provided with injection caps to assist in maintaining lumen sterility and patency, removable slide clamps for each lumen extension, and integral and moveable suture loops for securing the catheter at the insertion site. The device will be packaged in a Barex tray sealed with a Tyvek lid and sterilized using 100% ethylene oxide.

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

#### Indications for Use:

The Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ is indicated for use in patients requiring pressure monitoring, infusion of solutions, and blood sampling in the central vein. All catheters are manufactured with a polyurethane-based Oligon™ antimicrobial polymer. The Oligon™ material uses silver as the antimicrobial agent.

### Technology Comparison

The Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ is technologically comparable to the predicate devices in construction, materials, and physical specifications. Furthermore, design, manufacturing, and sterilization procedures are representative of current industry practices.

#### Test Summary, In-vitro

The non-clinical testing performed Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ included those set forth in the Draft Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters. The results of the in vitro testing demonstrate that the catheters meet the appropriate requirements of the ISO 10555-1 ("Sterile, single-use intravascular catheters -- Part 1: General requirements") and ISO 10555-3 ("Sterile, single-use intravascular catheters --Part 3: Central venous catheters) standards.

Functional testing was performed on the Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ to evaluate the integrity and performance of the device. Based upon the results of this testing, the Edwards Lifesciences LLC, has determined that the Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ is safe and effective and is acceptable in design and construction for its intended use.

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

Further in vitro testing was conducted to verify the antimicrobial properties of the Vantex™ Central Venous Catheters with Oligon™ material with or without AMC™ Thromboshield™ coating. The results of this testing demonstrate that the Oligon™ material provides antimicrobial effectiveness (≥ 3 log reduction within 48 hours) against the following organisms commonly associated with catheter related infections: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoacelicus, Corynebacterium diptheriae, Enterobacter aerogenes, Klebsiella pneumoniae, GMRSa, and Pseudomonas aeruginosa.

#### Test Summary, In-vivo

Clinical testing has been conducted in Canada to acquire safety data regarding silver, platinum, and benzalkonium chloride released from the Vantex ™ Central Venous Catheters with Oligon™ material with or without AMCTM Thromboshield™ coating. The purpose of this study was to determine the safety of the Oligon™ material by evaluating the silver and platinum levels in blood serum prior to, during, and after catheter use and to determine the safety of the AMC™ Thromboshield™ coating by evaluating the bezalkonium chloride levels in blood serum prior to, during, and after use. Safe levels of silver, platinum, and benzalkonium were found in both blood serum and urine during this study.

- Prior to market release of the product in Europe, a Marketing Evaluation was conducted to collect information on customer satisfaction with general performance characteristics of the Vantex™ Catheter. The clinicians expressed input as to the visibility of the catheter on a chest X-Ray. As a result of this feedback, Edwards Lifesciences modified the formulation of the Oligon™ material to include barium sulfate, which provides additional radiopacity to the catheter. The barium sulfate makes the radiopacity characteristic of the VantexTM Catheters comparable to that of the predicate Baxter Multi-Med® Catheters.

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

## Test Summary, Biocompatibility:

Biocompanibility testing was performed on the Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshicid™ (both Oligon™ formulations) in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Vantex™ Central Venous Catheter with Oligon™ matcrial with or without AMC™ Thromboshield™ (both Oligon™ formulations) was found to be biocompatible and nontoxic and acceptable for its intended use.

# Rationale for Substantial Equivalence Determinations:

The battery of non-clinical and clinical tests discussed above demonstrates that Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ for both the original and barium-filled Oligon™ formulations exhibits comparable mechanical and functional specifications to the predicate devices in addition to being biocompatible and chemically acceptable. Based upon those characteristics, Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ is substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

for Smith

son Smith Regulatory Affairs Associate Edwards Lifesciences LLC

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

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three lines forming its body and wings, and wavy lines representing water beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 7 - 2000

Mr. Jason Smith Regulatory Affairs Associate Edwards Lifesciences LLC One Edwards Way Irvine, California 92614

Re : K992532 Trade Name: Vantex™ Central Venous Catheter with OLIGON Material with or without AMC™ Thromboshield™ Coating Requlatory Class: II Product Code: FOZ Dated: March 14, 2000 Received: March 8, 2000

Dear Mr. Smith:

This letter corrects our substantially equivalent letter of June 13, 2000, regarding the Regulatory Class.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug

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

Page 2 - Mr. Smith

Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note; this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely.

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

| Page | of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

510(k) Number (if known); K992532

Vantex™ Central Venous Catheters with OLIGON™ material Device Name: with or without AMC™ Thromboshield™ coating

Indications For Use:

The Vantex™ Central Venous Catheter with OLIGON™ with or without AMC™ Thromboshield™ coating are indicated for use in patients requiring pressure monitoring, infusion of solutions, and blood sampling in the central vein. All catheters are manufactured with a polyurethane-based OLIGONTM antimicrobial polymer. The OLIGON™ material uses silver as the antimicrobial agent.

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use -------

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Patteux Cruccete

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_1992532