(300 days)
To facilitate endotracheal intubation in adult and pediatric patients where visualization of the glottis is inadequate.
The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age.
The subject device, the Frova Intubating Introducer is designed for establishing a pathway to introduce an endotracheal tube to a patient's airway. The intubation introducer is an 8 French, 35 cm long, single lumen catheter printed with incremental markings on the external surface. The introducer is made of radiopaque polyurethane and features a blunt and open distal tip with two sideports located on opposite sides of the distal tip. The introducer is compatible with an endotracheal tube with an inner diameter of 3.0 mm or larger.
The subject device intubation introducer is also preloaded with a stiffening stylet to provide extra stiffness to the introducer while it is being advanced into the patient's trachea. The stainless-steel stiffening stylet has an outer diameter of 0.051 inches and a length of 31 cm. A polyamide obturator hub is bonded to the stylet.
The subject device set also provides two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector) for ventilation when the oxygen requirement of a patient is high and the endotracheal tube is not in the trachea of the patient. The 15 mm Rapi-Fit adapter is intended for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is intended for attachment to a high-pressure jet ventilation oxygen source, and is compatible with a variable connector or the standard Luer fitting of an oxygen tube which is connected to an oxygen source.
Here's a breakdown of the acceptance criteria and the study information for the Frova Intubating Introducer, as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Catheter separation force with Rapi-Fit adapter | Separation force between catheter and adapter shall be greater than the catheter tensile force requirement (15 N). | The acceptance criterion was met. |
| Catheter shaft tensile strength | Peak load of specified catheter shaft section shall be greater than or equal to 15 N. | The acceptance criterion was met. |
| Catheter sideport tensile strength | Peak load of specified catheter shaft section shall be greater than or equal to 15 N. | The acceptance criterion was met. |
| Catheter shaft kink radius | Test articles shall pass the acceptance criteria as specified in ISO 5361. | The acceptance criteria were met. |
| Catheter shaft radiopacity | Radiopacity of the catheter shaft shall fall along the gradient of an aluminum X-ray step wedge gauge. | The acceptance criterion was met. |
| Stiffening stylet hub-to-shaft tensile | Peak load shall be greater than or equal to 15 N. | The acceptance criterion was met. |
| Design validation for pediatric use | Demonstrate that the Frova Intubation Introducer meets user needs and intended use for pediatric patients to assist intubation during difficult airway management procedures, when properly following the IFU. | The acceptance criteria were met. |
| Design validation for high pressure oxygenation insufflation during breathing simulator | No specific quantitative acceptance criteria are given in this document other than "Delivered minute volume and average maximum airway pressure were measured for each patient sub-group."Implied: performance should be acceptable for each subgroup. | No explicit "met" statement, but implies data was collected and analyzed for infant, child, adolescent, and adult patient subgroups using the ASL 5000 Breathing Simulator. |
| Biocompatibility testing | Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, volatile organic compound testing, and particulate matter testing. | Performed to ensure the biocompatibility of the subject device. |
| Acute performance evaluation on catheter via animal study | The catheter shall perform as intended in simulated clinical use. | The acceptance criteria were met. |
| Compatibility with ET tubes (for pediatric use validation) | Compatible with an endotracheal tube with an inner diameter of 3.0 mm and 3.5 mm. | The results demonstrate that the subject device introducer was compatible with an endotracheal tube with an inner diameter of 3.0 mm and 3.5 mm. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Sets for Physical/Mechanical Tests (Catheter separation force, tensile strength, kink radius, radiopacity, stylet tensile): The document doesn't explicitly state the sample size for each of these tests. It generally refers to "test articles" or "specified catheter shaft section." Data provenance is not specified but is implied to be from laboratory testing.
- Test Set for Design validation for pediatric use (Manikin Study): The document states that "airway training manikins that resemble appropriate patient anatomy of different sub-groups were used." It does not specify the exact number of manikins used or the number of trials. The data provenance is implicitly from a laboratory or simulation setting.
- Test Set for Design validation for high pressure oxygenation (Breathing Simulator): The document mentions using the "ASL 5000 Breathing Simulator from IngMar Medical" to simulate breathing profiles for "infant (> 1 month to 2 years old), child (> 2 years to 12 years old), adolescent (> 12 years through 21 years old), and adult (> 21 years old) patient sub-groups." The sample size (e.g., number of simulations, repetitions) is not specified. Data provenance is from a laboratory / simulator setting.
- Test Set for Biocompatibility: The document states "Biocompatibility testing Per ISO 10993-1 and FDA guidance." The sample size for these specific tests (cytotoxicity, sensitization, etc.) is not detailed in this document.
- Test Set for Acute performance evaluation (Animal Study): The document mentions "animal study" but does not provide the specific animal model, number of animals, or design of the study. Data provenance is from an animal study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for any of the described tests. The tests are primarily physical, mechanical, or simulation-based, or involve direct measurement against defined standards (e.g., ISO 5361, X-ray step wedge gauge).
4. Adjudication Method for the Test Set
Not applicable, as no expert-based ground truth establishment or subjective assessment requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or described in this document. The device is a medical introducer, not an AI or imaging diagnostic tool that would typically involve a multi-reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical introducer, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the various tests mentioned is based on:
- Engineering specifications and standards: For physical and mechanical tests (e.g., separation force, tensile strength, kink radius, radiopacity, stylet tensile), the ground truth is defined by specific numerical thresholds (e.g., >15 N) or compliance with international standards (ISO 5361).
- Simulated clinical performance: For pediatric use validation and high-pressure oxygenation studies, the ground truth is performance within expected physiological parameters or successful function in simulation models (manikins, breathing simulators).
- Biocompatibility standards: For biocompatibility, the ground truth is compliance with ISO 10993-1 and FDA guidance through specific toxicology tests.
- Animal study observations: For acute performance, the ground truth would be observed performance as intended in the animal model.
8. The Sample Size for the Training Set
Not applicable. The device is a medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned for this device.
§ 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).