(119 days)
The multiple-lumen catheter permits venous access to the central circulation. The Angiotech antimicrobial surface is intended to help provide protection against bacterial colonization on the catheter surface and it may help reduce catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for longer than 30 days use.
The Angiotech® CVC Multi-lumen Central Venous Catheter with MEDI-COATTM Antimicrobial Surface is a 7-French, polyurethane triple lumen, 15 or 20-cm catheter with a MEDI-COAT containing 48.8 µg/cm of 5-fluorouracil.
Here's a breakdown of the acceptance criteria and study information for the Angiotech CVC, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details various tests performed, but it mostly lists the types of tests without specific numerical acceptance criteria. For the clinical performance, the acceptance criterion seems to be non-inferiority to the predicate device regarding bacterial colonization prevention.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 10555-1 and ISO 10555-3 | Product meets all requirements. |
| Catheter stiffness performance | Performed. Results presumably met internal standards (no specific values given). |
| Catheter elongation performance | Performed. Results presumably met internal standards. |
| Catheter flexural fatigue tolerance performance | Performed. Results presumably met internal standards. |
| Priming volume (distal, medial, proximal lumen) performance | Performed. Results presumably met internal standards. |
| Flow rate (distal, medial, proximal lumen) performance | Performed. Results presumably met internal standards. |
| Biocompatibility | Undergone in vitro and in vivo testing; provides assurance for safety and effectiveness. |
| Zone of inhibition, minimal inhibitory concentration, minimal bactericidal concentration | Undergone in vitro testing; provides assurance for safety and effectiveness. |
| Mechanical and physical testing | Undergone testing; provides assurance for safety and effectiveness. |
| Drug release testing | Undergone testing; provides assurance for safety and effectiveness. |
| Non-inferiority for prevention of bacterial colonization | Proved effective and non-inferior compared to the predicate device in a prospective, randomized clinical trial. |
| Low rate of catheter-related bloodstream infection (CRBSI) | None in the Angiotech CVC group, two in the predicate device group. Comparison supported by "low rate." |
| Low and comparable rates of catheter insertion site infections | Rates were low and comparable in both groups. No adverse effects associated with clinical use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The sample size for the clinical trial is not explicitly stated. It mentions "adult patients in an ICU setting."
- Data Provenance: The data is from a prospective, randomized clinical trial. The country of origin is not specified but is implicitly assumed to be the USA, given the FDA 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. Clinical trials often involve medical professionals for assessment, but the text does not detail the number or qualifications of experts specifically for establishing ground truth related to the outcomes (e.g., bacterial colonization, infections).
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this an medical device, not an AI/Software device subject to such studies.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- No, this is a physical medical device (Central Venous Catheter) with an antimicrobial coating, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's performance is inherently "standalone" from human intervention in its antimicrobial action.
7. Type of Ground Truth Used
For the clinical trial, the "ground truth" was established by clinical outcomes data from patients. This includes:
- Prevention of bacterial colonization on catheters.
- Rate of catheter-related bloodstream infection.
- Rates of catheter insertion site infections.
These outcomes would be determined through standard microbiological and clinical diagnostic procedures.
8. Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI/software device that undergoes "training." The device's efficacy relies on its physical and chemical properties and its antimicrobial coating, which are developed through engineering and laboratory testing rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above (not an AI/software device). The development and testing of the antimicrobial coating (5-FU) and the catheter itself would involve various laboratory and pre-clinical studies, with "ground truth" derived from established scientific methods for assessing antimicrobial efficacy, material properties, and biocompatibility.
§ 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).