(386 days)
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous is intended to establish emergency airway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the percutaneous entry (Seldinger) technique via the cricothyroid membrane.
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing the surgical technique via the cricothyroid membrane.
The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is intended to establish emergency arrway access when endotracheal intubation cannot be performed. Airway access is achieved utilizing either the percutaneous entry (Seldinger) technique or the surgical technique via the cricothyroid membrane.
The Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical, and the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set consist of an airway catheter, a loading dilator, a wire guide, a catheter needle, and an introducer needle. In addition to these components, standard preparation components, such as a syringe, scalpel, dilator forceps, gauze, drape, tracheostomy tape, and tracheal hook are included. The sets consist of any combination of components appropriate for either percutaneous or surgical placement of a cricothyrotomy tube, or both.
The curved cricothyrotomy catheter is manufactured as a 22 French catheter with a length of 9 centimeters and an inner diameter of 5 millimeters. The loading dilators are either 11 centimeters or 12 centimeters long. The stainless steel wire guide has a 0.038-inch diameter and a length of 40 centimeters. The catheter needle is a two-part needle comprised of a small hubbed catheter sheath covering a hubbed needle. The sheath of the catheter needle is manufactured from fluorinated ethylene propylene tubing. The catheter needle is manufactured using an 18 gage cannula with a length of 7 centimeters. The introducer needle is also manufactured from 18 gage stainless steel and has a length of either 5 centimeters or 7 centimeters.
The provided document describes a 510(k) premarket notification for the Melker Cuffed Emergency Cricothyrotomy Catheter Set and its variations. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information provided relates to design validation and performance testing to ensure the device is as safe and effective as its predicate, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Durability of the Cuff (Zero-Time, Three-Year Accelerated Aging) | Cuff must remain fully intact and without any leaks following insertion. | The predetermined acceptance criterion was met. |
| Tensile Test of the Shaft of the Dilator (Three-Year Real-Time) | Dilator shaft must withstand a minimum force at break of 15 N. | The predetermined acceptance criterion was met. |
| Magnetically Induced Displacement Force (Per ASTM F2052) | Displacement force shall be less than or equal to the worst-case displacement force due to Earth's gravity. | The predetermined acceptance criterion was met. |
| Magnetically Induced Torque (Per ASTM F2213) | Magnetically induced torque shall be less than or equal to the worst-case torque due to Earth's gravity. | The predetermined acceptance criterion was met. |
| Radiofrequency Induced Heating | Electrical conductivity of the Melker Emergency Cricothyrotomy Catheter must be |
§ 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).