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510(k) Data Aggregation
(61 days)
The Agento™ I.C.® Silver-Coated Endotracheal Tube intended use is 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. 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.
The Bard Silver-Coated Endotracheal Tube is a sterile bifurcated (two lumen) 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 International Organization for Standardization (ISO) 5361, Anesthetic and Respiratory Equipment -Tracheal Tubes and Connectors. The Bard Silver-coated Endotracheal Tube is available with a hooded Murphy tip, a intermediate 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. The Bard 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 a Special 510(k) for a device modification of the Agento™ I.C.® Silver-Coated Endotracheal Tube. It primarily focuses on the regulatory submission and does not detail specific acceptance criteria or an analytical study with performance metrics in the format requested.
However, it does mention a key claim regarding the device's effectiveness. I will synthesize the available information to address as many of your points as possible, noting where information is not present in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduce incidence of microbiologically confirmed Ventilator Associated Pneumonia (VAP) | Reduced incidence of VAP from 7.5% (uncoated ET tubes) to 4.8% (Bard Silver-Coated ET tubes), representing a 36% reduction. Also delayed the time to onset of microbiologically confirmed VAP. |
| Maintain safety and effectiveness as predicate device | "Performance data have demonstrated that the subject device is as safe and effective as the predicate device." (No specific metrics provided in this document, but implied to meet an equivalence standard.) |
| Adherence to International Organization for Standardization (ISO) 5361 | Device features were tested in accordance with ISO 5361, Anesthetic and Respiratory Equipment - Tracheal Tubes and Connectors. (Implied compliance as part of safety and effectiveness.) |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size of a specific "test set" for the VAP reduction claim. It refers to a clinical finding: "incidences 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." This suggests a clinical study was performed, but the number of patients involved in that study is not provided here.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in this document.
3. Number of Experts and Their Qualifications for Ground Truth
This information is not provided in the document. The claim regarding VAP reduction would likely have been based on clinical diagnoses and microbiological confirmation, but the details of who made these determinations and their qualifications are not included.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human readers/AI assistance is present in this document. The device in question is a medical device (endotracheal tube), not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device, not a software algorithm.
7. Type of Ground Truth Used
Based on the description:
- For the VAP reduction claim: "microbiologically confirmed Ventilator Associated Pneumonia (VAP)". This indicates a ground truth established by clinical diagnosis and laboratory confirmation (microbiology).
- For safety and effectiveness compared to the predicate: Likely a combination of functional, biocompatibility, and possibly clinical endpoint data, but the specific "ground truth" definition for these comparisons is not detailed beyond demonstrating equivalence.
8. Sample Size for the Training Set
Not applicable in the context of an endotracheal tube's primary functional claims. There might be internal data from device development and testing, but it's not described as a "training set" in the sense of machine learning.
9. How Ground Truth for Training Set Was Established
Not applicable.
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