(267 days)
The Emergency Transtracheal Airway Catheter is intended for emergency airway access when conventional endotracheal intubation cannot be performed.
The Emergency Transtracheal Airway Catheter is composed of a catheter and needle. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The catheter is designed as a 6.0 French catheters manufactured from reinforced fluorinated ethylene propylene (FEP) tubing fitted to a 15 gage stainless steel needle with a lancet bevel. The nominal length of the catheter measures 5.0 or 7.5 centimeters, depending upon device specification. The catheter French size is stamped on the proximal fitting of the catheter. The Luer hub on the proximal end of the catheter connects to an oxygen source. The needle is manufactured with a nickel plated brass hub. The lancet bevel of the needle extends from the catheter at the beel of the bevel. The needle and the hub are soldered with tin-silver alloy material. The catheter-needle assembly cannulates the trachea through the cricothyroid membrane in order to establish an airway. The needle is removed from the catheter after the catheter-needle assembly establishes an airway through the cricothyroid membrane, leaving the catheter in the trachea.
The provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Emergency Transtracheal Airway Catheter meets these criteria. This submission is for a Class II medical device, and the evaluation focuses on showing substantial equivalence to a predicate device, rather than a de novo effectiveness study requiring advanced statistical modeling like MRMC analyses for AI performance. Therefore, many of the requested elements pertaining to AI models, such as sample sizes for test/training sets, expert qualifications for ground truth, or MRMC studies, are not applicable to this particular device submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design Validation (Zero Time): The test articles shall be able to access the trachea of an AirSim Advance Combo model when following the instructions provided in the Instructions for Use. | The acceptance criterion was met. |
| Bending Rigidity of the Needle (Zero Time): Peak load during compression within the specified deflection ≥ 7.5 N. | The acceptance criterion was met. |
| Insertion Force of the Needle (Zero Time): Determine the maximum compressive load. (Implicitly, this must be within acceptable clinical limits, though a specific numerical criterion is not provided explicitly in this summary). | The acceptance criterion was met. |
| Breaking Resistance (Zero Time): The cannula of the device withstands forces experienced during clinical use without breaking. | The predetermined acceptance criterion was met. |
| Air Leakage of the Catheter (Zero Time): Meet the air leakage requirements of BS EN ISO 10555-1. | The acceptance criterion was met. |
| Resistance to Overriding (Zero-Time): Meet the resistance to overriding requirements set forth in ISO 594-2. | The acceptance criterion was met. |
| Unscrewing Torque (Zero-Time): Meet the unscrewing torque requirements set forth in ISO 594-2. | The acceptance criterion was met. |
| Separation Force (Zero-Time): Meet the separation force requirements set forth in ISO 594-2. | The predetermined acceptance criterion was met. |
| Tensile Test of the Shaft of the Catheter (Three-year Accelerated Aging): Determine the peak tensile force of the shaft after accelerated aging to the real-time equivalent of 3 years. | The acceptance criterion was met. |
| Tensile Test of the Hub to Shaft Bond of the Catheter (Three-year Accelerated Aging): Determine the peak load of the hub-to-shaft bond after accelerated aging to the real-time equivalent of 3 years. | The acceptance criterion was met. |
| Tensile Test of the Hub to Cannula Bond of the Needle (Three-year Accelerated Aging): Needle cannula does not loosen from the hub when a tensile load of at least 20 N is applied (per ISO 11070) after accelerated aging. | The acceptance criterion was met. |
| Air Leakage of the Catheter (Three-year Accelerated Aging and Two-year Real Time Aging): Meet the air leakage requirements of BS EN ISO 10555-1 after accelerated aging to the real-time equivalent of 3 years. | The acceptance criterion was met. |
| Biocompatibility Testing: Meet appropriate requirements for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and material-mediated pyrogenicity (Per ISO 10993-1 and FDA guidance). | The predetermined acceptance criteria were met. |
| Five Year Accelerated Aging Report for Packaging Validation: Accelerated aging of the packaging system to the real-time equivalent of ≥ 5 years. | The acceptance criterion was met. |
| Sterility Testing: Meet appropriate requirements for bioburden, endotoxins, and EO and ECH residuals. | Testing confirms that the device meets the appropriate requirements for bioburden, endotoxins, and EO and ECH residuals. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. For many of the performance tests (e.g., bending rigidity, insertion force, air leakage, tensile strength), standard engineering and quality control practices would involve testing a representative sample from a production lot. The "Zero Time" and "Three-year Accelerated Aging" indicate testing was performed on new devices and devices subjected to simulated aging, respectively. Data provenance is not described as involving human patient data, but rather simulated or laboratory testing of the physical device. The document does not indicate country of origin for the data, but the manufacturer (Cook Incorporated) is based in Bloomington, IN, USA. The studies are prospective in the sense that they were designed and executed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical medical instrument, not an AI/software device whose performance relies on established ground truth from experts interpreting images or data. The "ground truth" here is determined by engineering specifications and physical measurements against international standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not an AI/software device requiring expert adjudication of results. Testing involved objective measurements against predefined engineering and material standards.
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 is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm-based device. "Standalone" performance testing for this device refers to the physical device's performance against specifications without human interaction other than the execution of the test protocols (e.g., measuring forces, leakage, etc.).
7. The Type of Ground Truth Used
The ground truth used for this device is based on engineering specifications and international standards. For example:
- Design Validation: Successful access to a validated anatomical model (AirSim Advance Combo model).
- Mechanical Properties: Numerical thresholds for bending rigidity (e.5 N), tensile load (20 N), maximum compressive load, breaking resistance, unscrewing torque, and separation force.
- Fluid Dynamics: Air leakage requirements of BS EN ISO 10555-1.
- Biocompatibility: Conformance to ISO 10993-1 and FDA guidance.
- Sterility: Conformance to requirements for bioburden, endotoxins, and EO/ECH residuals.
- Aging: Performance after simulated accelerated aging for 3 years (device) and 5 years (packaging) equivalent real-time.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set for an AI model.
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).