(322 days)
The Frova Intubating Introducer is intended to facilitate endotracheal intubation in patients where the visualization of the glottis in inadequate. The 14 French catheter has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.
The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque catheter introducer with centimeter markings and a blunt, curved tip that can be passed blindly into the trachea, when visualization of the glottis is inadequate and only visualization of the epiglottis can be confirmed by laryngoscopy. The catheter introducer has a tubular design with two distal sideports to ensure adequate airflow. It can be supplied with or without a stiffening stylet and/or two Rapi-Fit adapters for connection to a ventilator device. Pressure and flow specifications for the device when used for oxygenation are as follows: mean delivered minute volume is 8.6 L/min and mean measured average maximum airway pressure is 12.1 cm H2O (when input pressure is set to 50 psi, lung compliance is 100 mL/cm H2O, and resistance is 3 cm H2O/L/s). Incremental centimeter markings are placed on the shaft of the catheter introducer, with the first measurement marking designating 10 centimeters from the distal tip. The centimeter marks along the catheter shaft facilitate accurate depth placement of the catheter introducer into the airway.
The provided text describes the regulatory clearance of a medical device, the Frova Intubating Introducer, and includes details about its performance testing. However, it does not describe an AI/ML-driven device or diagnostic study.
Therefore, many of the requested elements for an AI/ML study (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, or type of ground truth) are not applicable to this document.
The document details engineering and performance validation tests for a physical medical device.
Here's the information that can be extracted relevant to the acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Time Zero Testing | ||
| Tensile strength (catheter introducer) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
| Tensile strength (stiffening stylet) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
| Tensile strength (catheter introducer/Rapi-Fit adapter connection) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
| Kink radius (catheter introducer) | No kinking at 40 mm Radius of Curvature (according to Annex H of ISO 5361:2012) | Met |
| Unscrewing torque (Luer Lock) | Female Luer connection remains attached to reference fitting (ISO 594-2, Section 5.5) | Met |
| Resistance to overriding (Luer Lock) | Reference fitting does not override threads of conical fitting (ISO 594-2, Section 5.7) | Met |
| Separation Force (Luer Lock) | Remains attached to the reference fitting (ISO 594-2, Section 5.4) | Met |
| Compliance verification (15mm adapter) | Leading edge of 15 mm Rapi-Fit adapter lies between minimum and maximum diameter step gauges (ISO 5356-1:2015, Section 3.1.2) | Met |
| Simulated Use | Each test article receives a rating of 2 or 3 on 3-point scale for each performance parameter. | Met |
| Oxygenation | 1. Able to insufflate oxygen under specified pressure. |
- Characterized delivered minute volume during simulated high pressure oxygenation insufflation.
- Successfully couples with Luer Lock Rapi-Fit adapter during simulated clinical use. | Characterization study performed, demonstrating the device's ability to insufflate oxygen, characterize delivered minute volume (mean 8.6 L/min, mean max airway pressure 12.1 cm H2O), and successful coupling with the Rapi-Fit adapter. |
| Transportation - Part 1 (Visual Inspection) | Damages accepted on shipping boxes as long as product boxes are without holes/loose pieces or damages due to humidity. Small visible damages like pressure marks allowed on product boxes, as long as sterile barrier and Frova catheter are intact. | All acceptance criteria were met. |
| Transportation - Part 2 (Sterile Barrier) | No breaches in sterile barrier, no visual tears or pinholes. | All acceptance criteria were met. |
| Transportation - Part 3 (Device Integrity) | Catheter introducer has a curved tip after simulated shipping test. No kinks or damages. For C-CAE-14.0-70-FII, adapter attaches/locks to catheter introducer per IFU, not removable by pulling when locked, and removable from catheter introducer per IFU. | All acceptance criteria were met. |
| Ink adherence and radiopacity | Each test article receives a rating of 2 or 3 on a 3-point scale for legibility of printed markings and radiopacity. | All acceptance criteria were met. (Performed as simulated use testing in domestic swine) |
| Accelerated Age Testing | (Equivalent of three years real time aging) | |
| Tensile strength (catheter introducer) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
| Tensile strength (stiffening stylet) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
| Tensile strength (catheter introducer/Rapi-Fit adapter connection) | ≥ 15 N (accordance with EN/ISO 10555-1:2013) | Met |
| Kink radius (catheter introducer) | No kinking at 40 mm Radius of Curvature (according to Annex H of ISO 5361:2012) | Met |
| Unscrewing torque (Luer Lock) | Female Luer connection remains attached to reference fitting (ISO 594-2, Section 5.5) | Met |
| Resistance to overriding (Luer Lock) | Reference fitting does not override threads of conical fitting (ISO 594-2, Section 5.7) | Met |
| Separation Force (Luer Lock) | Remains attached to the reference fitting (ISO 594-2, Section 5.4) | Met |
| Compliance verification (15mm adapter) | Leading edge of 15 mm Rapi-Fit adapter lies between minimum and maximum diameter step gauges (ISO 5356-1:2015, Section 3.1.2) | Met |
| Sterile barrier and dimensional verification | Sterile barrier intact (bubble leak/dye test). Product appears intact visually. Tip angle within tolerances. Length 70 cm ± 3mm. ID 3.124 mm ± 0.05 mm. OD 4.674 mm ± 0.05 mm. Print clear and visible within tolerances. Rapi-Fit adapters attach and lock per IFU. | All acceptance criteria were met. |
| Ink adherence and radiopacity | Each test article receives a rating of 2 or 3 on a 3-point scale for legibility of printed markings and radiopacity. | All acceptance criteria were met. (Performed as simulated use testing in domestic swine) |
| Biocompatibility | | |
| Cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material mediated pyrogenicity | Passed results in accordance with ISO 10993-1:2009 and FDA guidance. | All biocompatibility tests showed passed results. |
| Volatile organic compounds (VOCs) | No VOCs detected greater than quantification limits; no additional VOCs detected. | No VOCs detected greater than quantification limits; no additional VOCs detected. Risk assessment determined negligible likelihood of toxic effect. |
| Particulate matter emission | Presents a clinically insignificant health risk to patients. | Results demonstrated clinically insignificant health risk. |
Regarding the AI/ML-specific questions:
- Sample size used for the test set and the data provenance: Not applicable; this is not an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; this is not an AI/ML device.
- Adjudication method: Not applicable; this is not an AI/ML device.
- 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 is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/ML device.
- The type of ground truth used: For physical characteristics, the ground truth is established by physical measurement against established specifications (e.g., tensile strength, dimensions, kink radius, Luer Lock standards, adapter fit, sterile barrier integrity). For biological safety, it's defined by the results of standardized biocompatibility tests. For simulated use, it involves performance ratings in a simulated environment or animal model (domestic swine).
- The sample size for the training set: Not applicable; this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable; this is not an AI/ML 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).