(316 days)
The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients.
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 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
The Cook Airway Exchange Catheter - Extra-Firm with Soft Tip is intended for endotracheal tube exchange in adult and pediatric patients.
The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age.
The 14 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 2 years of age.
The Arndt Airway Exchange Catheter Set is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The product may be used for emergency, urgent, and elective airway management.
The 14 French catheter is recommended for placement of an endotracheal tube or a supraglottic airway device with an inner diameter of 5 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 14 French catheter is recommended for patients older than 12 years of age.
The Aintree Intubation Catheter is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients.
The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger.
When used for high-pressure oxygenation with a Luer lock connector, the 19 French catheter is recommended for patients older than 12 years of age.
The Respiratory Management Sets are a family of airway management products, designed for establishing, re-establishing, or maintaining an airway. The catheters may be manufactured from polyurethane or polyethylene. They are single lumen catheters and are designed with a blunt or tapered distal tip. Incremental markings on the catheter shafts facilitate the accurate placement of the catheters into the airway. The subject device catheters have sideports at the distal end and the subject devices are provided with two Rapi-Fit adapters for ventilation when oxygen requirement is high and the supraglottic airway device or endotracheal tube is not in the trachea of the patients.
The Aintree Intubation Catheter is comprised of an intubation catheter, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The intubation catheter is made of polyurethane and is 19 Fr in diameter and 56 cm long. The distal end of the intubation catheter is open and designed with a straight and tapered tip, with two sideports aligned opposite to each other.
The Arndt Airway Exchange Catheter Set is comprised of an exchange catheter, a wire guide, two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector), and a double swivel connector. The catheter is made of polyurethane and is 14 Fr in diameter and 70 cm long. The distal end of the exchange catheter is open and designed with a straight and tapered tip, with six sideports spiraled along the distal tip.
The Cook Airway Exchange Catheter is comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The 8, 11, and 14 Fr catheters are made of polyurethane, while the 19 Fr catheter is made of polyethylene. The 8 Fr catheter is 45 cm long, while the 11, 14, and 19 Fr catheters are 83 cm long. The distal ends of the exchange catheters are open and designed with a straight and tapered tip. The 8 Fr, 14 Fr, and 19 Fr catheters have two sideports aligned opposite to each other, while the 11 Fr catheter has six sideports spiraled along the distal end.
The Cook Airway Exchange Catheter – Extra-Firm with Soft Tip are comprised of an exchange catheter and two Rapi-Fit adapters (one with a 15 mm connector, and one with a Luer lock connector). The exchange catheter is made of polyurethane intermittent extrusion tubing, with a stiff shaft and a softer distal 7 cm of the catheter is made of a softer and more flexible polyurethane). The catheter is available in diameters of 11 or 14 Fr, and a length or 100 cm. The distal ends of the exchange catheters are open and designed with a straight and blunt tip. The 11 Fr catheter has six sideports spiraled along the distal end, while the 14 Fr catheter has two sideports aligned opposite to each other.
This document is a 510(k) premarket notification for several airway management devices from Cook Incorporated. It outlines the devices, their intended use, comparison to a predicate device, and performance testing conducted.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several performance tests and states that "The acceptance criterion was met" for each. Specific quantitative acceptance criteria or detailed performance results are generally summarized as "met," rather than providing precise numerical values.
| Test Category | Specific Test | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Catheter shaft tensile (Zero time and aged) | Peak load $\geq$ applicable load requirement (BS EN ISO 10555-1) | Met |
| Catheter sideport tensile (Zero time and aged) | Peak load $\geq$ applicable load requirement (BS EN ISO 10555-1) | Met | |
| Rapi-Fit adapter-to-catheter attachment (Aged) | Separation force $\geq$ catheter tensile force requirement | Met | |
| Wire guide tensile (Zero time and aged) | Peak load of failure $\geq$ 10 N (Annex H of BS EN ISO 11070) | Met | |
| Wire guide flex (Zero time and aged) | No defects or damage after repeat flexing (Annex G of BS EN ISO 11070) | Met | |
| Wire guide fracture (Zero time and aged) | No fracture when wound around appropriate former (Annex F of BS EN ISO 11070) | Met | |
| Luer Lock hub of Rapi-Fit Adapter unscrewing torque | Met (Sections 4.4 and 5.5 of ISO 594-2) | Met | |
| Luer Lock hub of Rapi-Fit Adapter resistance to overriding | Met (Sections 4.6 and 5.7 of ISO 594-2) | Met | |
| Luer Lock hub of Rapi-Fit Adapter separation force | Met (Sections 4.3 and 5.4 of ISO 594-2) | Met | |
| 15-mm hub of Rapi-Fit Adapter compliance verification | Met (Section 3.1.2 of ISO 5356:2015) | Met | |
| Device Characteristics & Functionality | Catheter shaft radiopacity (Zero time and aged) | Fall along the gradient of an aluminum X-ray step wedge gauge | Met |
| Catheter shaft kink radius (Aged) | Meets kink requirement (Annex H of ISO 5361:2012) | Met | |
| High pressure oxygenation insufflation | Delivered minute volume and average maximum airway pressure measured for various patient subgroups (implicit acceptance of safe and effective delivery) | Met | |
| Catheter dimensional and ink marking verification | Length and ink marking verified (implicit acceptance of meeting specifications) | Met | |
| Double Swivel Connector compatibility analysis | Catheters can be inserted and removed through septum into an endotracheal tube | Met | |
| Biocompatibility | Biocompatibility testing | Meets ISO 10993-1 and FDA guidance for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and material-mediated pyrogenicity. | Met |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for each test. The data provenance is internal testing conducted by Cook Incorporated as part of their 510(k) submission. No information is provided regarding country of origin or whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes performance testing for medical devices (catheters, wire guides, adapters). For these types of physical/mechanical tests, "ground truth" is typically established by engineering specifications, accepted industry standards (e.g., ISO, BS EN ISO), and established testing methodologies, rather than expert clinical consensus or pathology. Therefore, there is no mention of human experts establishing ground truth for the technical performance tests described.
4. Adjudication Method for the Test Set
Not applicable. As described above, the acceptance is based on meeting predefined technical specifications and standards, not on human adjudication of subjective data.
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
Not applicable. This submission is for physical medical devices (catheters and their accessories), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for physical medical devices, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests described is based on engineering specifications and established international standards (e.g., BS EN ISO 10555-1, ISO 5361:2012, BS EN ISO 11070, ISO 594-2, ISO 5356:2015, ISO 10993-1). For biocompatibility, it's based on adherence to ISO standards and FDA guidance.
8. The Sample Size for the Training Set
Not applicable. This is for physical medical devices, which do not have a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or relevant for these devices.
§ 868.5790 Tracheal tube stylet.
(a)
Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.