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510(k) Data Aggregation
(90 days)
VYGON S A
The Boussignac/ Vygon Endotracheal Tube is indicated for airway management. The insufflation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a supplemental means for administering oxygen during bronchoscopies. In these ventilatory modes, the main lumen serves as a channel for the elimination of expired gases. When the insufflation port is capped, The Boussignac/ Vygon Endotracheal Tube can function as a standard tracheal tube with ventilation occurring through the main lumen. The Boussignac/ Vygon Endotracheal Tube is intended for oral/nasal intubation.
The monitoring/irrigation lumens may be used for monitoring airway pressure, for irrigation of a patient's tracheobronchial tree, to aid in the removal of accumulated secretions, for sampling tracheal gases, for anesthetizing the trachea, or for introducing suitable medication in accordance with standard medical practice.
The Boussignac/ Vygon Endotracheal Tube is a standard endotracheal tube available in pediatric and adult use. The tube design includes a Magill curve, a tip, printed depth markings (in one centimeter increments), a low-pressure cuff (adult models only) and self-sealing valve with attached pilot balloon for cuff inflation/deflation. The tube also features a radiopaque line to assist in radiographic visualization. The device, including featured characteristics listed above, conforms to ISO 5361: Anesthetic and Respiratory Equipment – Tracheal Tubes and Connectors.
The tube has a main lumen and eight (8) separate canals, or "capillaries", embedded in the tube wall. For adult models, six (6) of these canals are used for gas insufflation, two (2) for pressure control, CO2 monitoring, or irrigation, and as in any endotracheal tube, one (1) for pressure control. CO2 monitoring, or irrigation. For the uncuffed pediatric model, six (6) of the imbedded canal is reserved for gas insufflation, while two (2) are used for pressure control, CO2 monitoring, or irrigation.
The provided text is a 510(k) summary for the Boussignac/Vygon Endotracheal Tube. It does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the request.
The document primarily focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and comparison to existing products. It mentions "Performance testing was presented" and "Clinical publications were presented" but does not elaborate on the details or results of these tests.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
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(424 days)
VYGON S A
The Boussignac® C.P.A.P. Device is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
The Boussignac® C.P.A.P. Device is a sterile, single-use, respiratory aid device intended for use with a facemask and gas-supplying device to elevate pressure in a patient's lung. Alternatively, the device may be used in conjunction with an endotracheal tube (via a specific Vygon adapter) to generate and maintain constant positive airway pressure during standard intubation procedures.
The upper, or proximal, port of the device may be connected to a gas-supplying source via an attached connecting tube, while the lower, or distal port may provide for C.P.A.P. pressure monitoring, O2 monitoring, or an additional source of oxygen in the event that the gas administered to the patient via the proximal connection is air not enriched with oxygen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Boussignac® C.P.A.P. Device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Description | Reported Device Performance (Summary of Non-Clinical Tests / Conclusions) |
|---|---|
| Pressure decrease with inhalation is not excessive. | Data demonstrated that pressure decrease with inhalation is not excessive. |
| Pressure increase with exhalation is not excessive. | Data demonstrated that pressure increase with exhalation is not excessive. |
| Pressure decrease with inhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. | Data demonstrated that pressure decrease with inhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. |
| Pressure increase with exhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. | Data demonstrated that pressure increase with exhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "non-clinical tests" and explicitly states "Summary of Clinical Tests (Not Applicable)." This indicates that the performance evaluation was based on bench testing/laboratory experiments, not on a test set of patient data. Therefore, questions regarding patient sample size, country of origin, or retrospective/prospective nature are not directly applicable to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As the study was non-clinical (bench testing), there were no patient "cases" or ground truth established by medical experts in the traditional sense. The "ground truth" for these tests would likely be established metrics or engineering specifications for pressure changes.
4. Adjudication Method for the Test Set
Not applicable. Since there were no expert assessments of patient data, there was no need for an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states "Summary of Clinical Tests (Not Applicable)," meaning no clinical studies, including MRMC studies, were performed. This device is not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in a sense. The "non-clinical tests" represent the standalone performance of the device itself (not an algorithm in this context). The device was tested in a controlled environment to ensure it met specific physical performance criteria related to pressure regulation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be engineering specifications or established physical parameters for acceptable pressure variations in CPAP devices, likely derived from industry standards or a comparison to predicate devices. The document implies these tests demonstrate equivalence to predicate devices, suggesting the predicate device's performance characteristics served as a reference.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical respiratory aid, not an algorithm-based device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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