(396 days)
Endotracheal tube is intented for oral or nasal intubation and for airway management.
Tracheal Tube uncuffed (chart 1) and with cuffed (chart uncuffed of Tracheal Tube only make up of body and connector. Tracheal Tube with cuffed make up of body and connector、cuff、inflating tube、Pilot balloon、Valve。Tracheat tube with a radius of curvature.。 a line for x-radial through the body.。 All tubes have an angle of 38±10° . Length marks in centimeters measured from the patient end. The murphy eye on the side of the tube opposite the bevel. The tube machine end have the connector .It can connect the anesthesia machine or respiratory equipment. The inflating pilot balloon includes a valve fitting with a 6% (Luer) taper.
Each tracheal tube was contained in an individual pack . Sterilized by EOT. Single use only
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Endotracheal Tube) and primarily focuses on establishing substantial equivalence to a predicate device.
Specifically, the document states:
- "There are no new safety concerns when compared to the already available predicate devices. For these reasons, we feel the Chilecom Tracheal tube fulfills all criteria to be found substantially equivalent to the predicate devices and should be cleared for marketing." This indicates that the primary method of demonstrating safety and effectiveness is through comparison to existing device, rather than through a detailed performance study with acceptance criteria.
- "Performance Characteristics (If/when applicable) J. 1. See the Exhibits." However, the exhibits themselves are not provided in the given text.
Therefore, I cannot provide the requested information.
§ 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).