Search Results

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.

The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.

The provided text is a 510(k) Summary for JEM Endotracheal Tube Changers. It describes the device, its intended use, and the purpose of the 510(k) submission, which is to add ethylene oxide as an alternate sterilization method and to expand the user instructions.

However, the provided document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document is a Special 510(k) submission, which means it addresses minor changes to a previously cleared device. In such a submission, the focus is typically on demonstrating that the changes do not alter the substantial equivalence of the device, rather than conducting new performance studies against acceptance criteria for the core functionality. The original PMS submission (Premarket Approval of the JEM 400 in 1981) would have contained such data, but it is not included in this document.

Therefore, I cannot provide the requested information from the given text.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

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.

Ask a specific question about this device