(175 days)
The Agento™I.C.® silver-coated endotracheal tube is indicated for airway management by oral or nasal intubation of the trachea for anesthesia and in cases where duration of intubation is expected to be 24 hours or longer, or may be unpredictable.
The Agento™ I.C.® silver-coated endotracheal tube has been shown to reduce the incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP) in patients intubated for 24 hours or longer from an incidence of 7.5% in patients intubated with uncoated ET tubes to an incidence of 4.8% in patients intubated with the Bard Silver-Coated ET tubes (reduction of 36%) and to delay the time to onset of microbiologically confirmed VAP.
For Adults Only
Agento™ I.C.® silver-coated endotracheal tube is a sterile bifurcated (twolumen) polyvinyl chloride tube with a polyvinyl chloride cuff. The tube design incorporates a Magill curve and features a radiopaque line to assist radiographic visualization. An indicator (ORAL: NASAL) is provided on standard length tubes to mark the tracheal tube length in centimeters. This indicator and all other device features listed above were tested in accordance with the American Society for Testing and Materials ("ASTM") designation F 1242-96, Standard Specification for Cuffed and Uncuffed Tracheal Tubes. The Bard Silver-coated Endotracheal Tube is available with a hooded Murphy tip, a high volume, low pressure cuff and self-sealing valve with attached pilot balloon. The Bard Silver-coated Endotracheal Tube is available in sizes of 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm ID.
Agento™ I.C.® silver-coated endotracheal tube is coated on the outer endotracheal tube surface, including the cuff surface, and on the interior surface of the airway lumen with a proprietary hydrophilic silver coating. Neither the inside of the cuff nor the inside of the inflation lumen is coated.
The provided text describes the Agento™ I.C.® Silver-coated Endotracheal Tube and its performance related to Ventilator Associated Pneumonia (VAP) reduction.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction in the incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP). | The Agento™ I.C.® silver-coated endotracheal tube has been shown to reduce the incidence of microbiologically confirmed VAP in patients intubated for 24 hours or longer from an incidence of 7.5% in patients intubated with uncoated ET tubes to an incidence of 4.8% in patients intubated with the Bard Silver-Coated ET tubes (reduction of 36%). |
| Delay in the time to onset of microbiologically confirmed VAP. | The Agento™ I.C.® silver-coated endotracheal tube has been shown to delay the time to onset of microbiologically confirmed VAP. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Clinical studies of the Agento™ I.C.® silver-coated endotracheal tube demonstrated a reduction in the incidence and time to onset of VAP compared to the predicate uncoated endotracheal tube."
However, the specific sample size (N) for the test set is NOT provided in the given text.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the statement "Clinical studies... demonstrated a reduction..." implies a prospective clinical trial design, comparing outcomes between the silver-coated ET tubes and uncoated ET tubes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not provide information on the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
The document focuses on the effectiveness of the device itself in reducing VAP, not on the performance of human readers with or without AI assistance. Therefore, an MRMC comparative effectiveness study was NOT done (as it's not applicable to this type of device where the device directly impacts a clinical outcome rather than assisting human interpretation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is an endotracheal tube, not an algorithm or AI system for diagnostic interpretation. Its performance is measured by its direct clinical impact.
7. The Type of Ground Truth Used:
The ground truth used for assessing the device's performance is "microbiologically confirmed Ventilator Associated Pneumonia (VAP)." This implies a combination of clinical criteria and laboratory confirmation (e.g., cultures, diagnostic tests) to definitively identify VAP.
8. The Sample Size for the Training Set:
This question is not applicable as the Agento™ I.C.® Silver-coated Endotracheal Tube is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as the device is not an AI/ML algorithm.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).