(128 days)
The ARROWg ard Blue Plus™ antimicrobial catheter is indicated in the short-term (
The device is a triple-lumen, polyurethane catheter, 7 French in size, with three independent non-communicating lumens, extension lines, Luer hubs and slide clamps. It is identical in appearance and function to the ARROW predicate catheter except for the increased amount of chlorhexidine acetate and silver sulfadiazine on the external surface and the addition of the internal lumen chlorhexidine and chlorhexidine acetate impregnation.
This document is a 510(k) Premarket Notification for the ARROWg†ard Blue Plus™ Antimicrobial Central Venous Catheter. It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission outlines performance tests and states that the device is "as safe as and is more effective than the legally marketed predicate device." However, specific numerical acceptance criteria (e.g., "X% reduction in infections") and corresponding quantitative performance metrics are not explicitly stated in the provided text. The evaluation is based on a comparison to a predicate device and the results of various in vitro and in vivo studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| In vitro efficacy: Sufficient antimicrobial activity (zone of inhibition) | Demonstrated efficacy |
| In vitro efficacy: Reduced internal lumen adherence of microorganisms | Demonstrated efficacy |
| In vitro performance: Adequate release rate of antimicrobial agents | Demonstrated efficacy |
| Mechanical Integrity (Tensile strength, Fatigue life): Comparable to or better than a predicate device | Met, device is "as safe as" predicate |
| Stability: Maintained over time | Demonstrated |
| Biocompatibility: Safe for biological contact | Demonstrated |
| In vivo safety (swine): No unacceptable adverse reactions | Demonstrated safety |
| In vivo half-life: Maintained antimicrobial activity over time in vivo | Demonstrated |
| In vivo delayed inoculum: Protection against infection in a living system | Demonstrated efficacy and "more effective than" predicate |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for the in vitro or in vivo tests. It only lists the types of tests performed.
- Data Provenance: The studies are described as "in vitro" (laboratory-based) and "in vivo" (using swine). No information on the country of origin or whether the studies were retrospective or prospective is detailed. However, animal studies are inherently prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish "ground truth" in the context of human interpretation or diagnosis. The studies are laboratory and animal-based performance tests where "ground truth" would be determined by scientific measurements and observations, not expert consensus on medical images or clinical cases.
4. Adjudication Method for the Test Set
As the test set primarily consists of laboratory and animal studies, and not human-interpreted data requiring consensus, an adjudication method (like 2+1, 3+1) is not applicable and therefore not mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that an MRMC comparative effectiveness study was done. The studies mentioned are focused on the device's inherent performance and safety characteristics, not on how human readers' performance might improve with the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to a physical medical device like a central venous catheter. The device itself is the "standalone" component being evaluated for its physical, chemical, and biological performance. There is no algorithm or human-in-the-loop component in its function.
7. Type of Ground Truth Used
The ground truth for the performance studies would be based on:
- In vitro measurements: e.g., zone of inhibition diameters, release rates, tensile strength values, microbial adherence counts.
- In vivo observations: e.g., absence/presence of infection in animal models, measured half-life of antimicrobial agents in tissue, safety endpoints (adverse reactions).
8. Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning algorithms. For a physical medical device, there isn't a "training set" in this sense. The device's design and manufacturing processes are refined through engineering, material science, and iterative testing, not through training data in an AI context. Therefore, a sample size for a training set is not applicable or provided.
9. How the Ground Truth for the Training Set Was Established
Given that there is no "training set" in the AI sense for this device, the question of how its ground truth was established is not applicable. The "ground truth" for the device's design and production would be established through established engineering principles, material specifications, and quality control processes.
§ 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).