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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantex™ Central Venous Catheter:

Acceptance Criteria and Device Performance Study for Vantex™ Central Venous Catheter

The Vantex™ Central Venous Catheter with Oligon™ material with or without AMC™ Thromboshield™ coating underwent a series of in-vitro and in-vivo tests to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
In-vitro Functional & Physical	Meets appropriate requirements of ISO 10555-1 ("Sterile, single-use intravascular catheters -- Part 1: General requirements")	Catheters met the appropriate requirements of ISO 10555-1.
	Meets appropriate requirements of ISO 10555-3 ("Sterile, single-use intravascular catheters -- Part 3: Central venous catheters")	Catheters met the appropriate requirements of ISO 10555-3.
	Integrity and performance of the device are maintained.	Functional testing demonstrated the integrity and performance of the device. The device was determined to be safe, effective, and acceptable in design and construction for its intended use.
In-vitro Antimicrobial	Antimicrobial effectiveness (≥ 3 log reduction within 48 hours) against specified 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).	The Oligon™ material provided antimicrobial effectiveness (≥ 3 log reduction within 48 hours) against all specified organisms: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoacelicus, Corynebacterium diptheriae, Enterobacter aerogenes, Klebsiella pneumoniae, GMRSa, and Pseudomonas aeruginosa.
In-vivo Safety (Chemical Release)	Safe levels of silver, platinum, and benzalkonium chloride in blood serum and urine during and after catheter use.	Clinical testing found safe levels of silver, platinum, and benzalkonium in both blood serum and urine during the study.
Radiopacity	Radiopacity comparable to predicate Baxter Multi-Med® Catheters.	Initially, feedback indicated a need for improved radiopacity. The Oligon™ material formulation was modified to include barium sulfate, resulting in radiopacity comparable to the predicate Baxter Multi-Med® Catheters.
Biocompatibility	Biocompatible and non-toxic according to ISO 10993-1-1994 and FDA General Program Memorandum No. G95-1.	Biocompatibility testing confirmed the Vantex™ Catheter (both Oligon™ formulations) was biocompatible, non-toxic, and acceptable for its intended use, adhering to ISO 10993-1-1994 and FDA G95-1.
Substantial Equivalence	Comparable mechanical and functional specifications, biocompatibility, and chemical acceptability to predicate devices.	The battery of non-clinical and clinical tests demonstrated comparable mechanical and functional specifications, biocompatibility, and chemical acceptability to the predicate devices for both original and barium-filled Oligon™ formulations. This formed the basis for a determination of substantial equivalence in safety and effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

In-vitro Testing: The document does not specify a numerical sample size for the in-vitro functional, physical, or antimicrobial testing. It simply states that "functional testing was performed" and "further in vitro testing was conducted." The provenance is not explicitly stated beyond "in-vitro."
In-vivo Clinical Testing: The in-vivo testing (for chemical release) was conducted in Canada. The document does not specify the numerical sample size of patients included in this study, nor does it explicitly state if it was retrospective or prospective, though the nature of measuring levels "prior to, during, and after catheter use" suggests it was prospective.
Marketing Evaluation (Radiopacity Feedback): This was a "Marketing Evaluation conducted to collect information on customer satisfaction" in Europe. The sample size of clinicians or feedback instances is not specified. This would inherently be prospective in its data collection from clinicians, even though it led to a product modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

In-vitro & Biocompatibility Testing: Not applicable in the context of expert ground truth for a test set, as these are lab-based tests against established standards.
In-vivo Clinical Testing (Chemical Release): The document doesn't mention "experts" specifically establishing ground truth in terms of diagnoses or interpretations. The "ground truth" for chemical levels would be the objective measurements themselves.
Marketing Evaluation (Radiopacity Feedback): "Clinicians" provided feedback. Their specific number or qualifications (e.g., "radiologist with 10 years of experience") are not detailed. Their input served as qualitative feedback rather than establishing a formal ground truth for a diagnostic test.

4. Adjudication Method for the Test Set

Not applicable (N/A). The provided document describes tests against objective standards (ISO, chemical measurements, biological responses) or general clinician feedback, not a scenario requiring an adjudication method for conflicting interpretations of a test set by multiple readers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document primarily focuses on demonstrating that the device meets safety and performance standards and is substantially equivalent to predicate devices. It does not evaluate the improvement of human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable (N/A). This device is a physical central venous catheter, not an AI algorithm or software. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant here.

7. The Type of Ground Truth Used

In-vitro: Objective Standards and Laboratory Measurements. For functional, physical, and antimicrobial testing, the ground truth was established by adherence to recognized international standards (ISO 10555-1, ISO 10555-3) and measurable laboratory outcomes (e.g., log reduction for antimicrobial effectiveness).
In-vivo: Biological Measurements. For the chemical release study, the ground truth was the measured concentrations of silver, platinum, and benzalkonium chloride in blood serum and urine.
Biocompatibility: Standardized Biological Responses. Ground truth was determined by the results of standardized biological tests according to ISO 10993-1-1994, indicating acceptable biological response.
Radiopacity: Comparative Visual Assessment/Clinician Feedback. Initially, clinician feedback in Europe highlighted a lack of radiopacity. The modified product's radiopacity was then compared visually/analytically to a predicate device to ensure comparability.

8. The Sample Size for the Training Set

Not applicable (N/A). This document describes the testing of a physical medical device, not the development or training of an AI algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable (N/A). As there is no AI algorithm training set, this question is not relevant.

Summary

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510(k) Summary, Safety and Effectiveness	1992532
Submitter:	Edwards Lifesciences, LLC17221 Red Hill AvenueIrvine, California 92614 USA
Contact:	Jason SmithPhone: 949-250-2662Fax: 949-756-4021
Device Trade Name:	VantexTM Central Venous Catheter with OligonTMmaterial with or without AMCTM ThromboshieldTMcoating
Common Name:	Central Venous Catheter
Classification:	Class II (Reference 21 CFR 880.5200)
Predicate or LegallyMarketed Device:	Multi-Med Multi-Lumen Central Venous Catheterwith AMCTM ThromboshieldTM and ArrowInternational's Central Venous Multi-LumenCatheter with ARROWgard Blue
Date prepared:	July 27, 1999

Device Description

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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.

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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.

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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

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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

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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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510(k) Number (if known); K992532

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

Indications For Use:

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use

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

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).