(27 days)
The Frova Intubating Introducer is indicated to facilitate endotracheal intubation in patients where visualization of the glottis is inadequate e.g., as in grade II and III Cormack-Lehane views. This indication applies for introduction of a single lumen endotracheal tube with an inner diameter of 6 mm or larger.
The Frova Intubating Introducer is also designed for transient oxygenation or jet ventilation in combination with 14 Fr compatible Rapi-Fit Adapters (15 mm and female Luer lock connector). The Rapi-Fit Adapters should only be used when oxygen requirements are high.
The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque introducer with centimeter markings and a blunt, curved tip that can be passed into the trachea. The introducer has a through lumen design with two distal sideports to ensure adequate airflow. The Frova Intubating Introducer can be supplied with a stiffening stylet and two Rapi-Fit® Adapters for connection to an oxygen source.
The Frova Intubating Introducer is designed to facilitate airway intubation and allows for transient oxygenation and/or jet ventilation during the initial intubation.
The Rapi-Fit Adapter with a 15 mm connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation during intubation.
The Rapi-Fit Adapter with a female Luer lock connector is intended for use with a 14 Fr Frova Intubating Introducer for connection to an oxygen source to facilitate transient oxygenation or jet ventilation during intubation.
The stiffening stylet is intended to add rigidity to the proximal and middle sections of the introducer, while the distal portion remains flexible.
The different configurations of the Frova Intubating Introducer are supplied sterile and are for single use only.
Based on the provided FDA 510(k) Clearance Letter for the Frova Intubating Introducer, it is explicitly stated that no performance testing was warranted in support of this 510(k) premarket notification. Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The reason provided is: "No changes to the design, manufacturing, sterilization, or principles of operation have been introduced with the subject device. Therefore, no performance testing was warranted in support of this 510(k) premarket notification." This indicates that the clearance relies on its substantial equivalence to a previously cleared predicate device (K161813), and the proposed changes are limited to labeling harmonization.
Consequently, I cannot fill out the requested information regarding acceptance criteria and performance studies from this document. If this were a new device or a device with significant changes, such information would be crucial for its clearance.
Here's a breakdown of why each section cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document explicitly states no performance testing was warranted.
- Sample sizes used for the test set and the data provenance: Not applicable, as no performance testing was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance testing was conducted.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no performance testing was conducted.
- 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: Not applicable. This device is a physical medical introducer, not an AI or software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical introducer, not an AI or software device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance testing was conducted.
- The sample size for the training set: Not applicable, as no performance testing was conducted (and no training set would be relevant for a physical device in this context).
- How the ground truth for the training set was established: Not applicable, as no performance testing was conducted.
§ 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).