(320 days)
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.
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.
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.
§ 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).