Search Results

The DUTAU-NOVATECH® is intended for rigid bronchoscopy. For use in trachea and bronchi. To be used by qualified surgeons during ENT endoscopic procedures. The DUTAU-NOVATECH® is suitable for use for a patient population greater than 5 years of age.

DUTAU-NOVATECH® is a rigid bronchoscope that consists of a bronchoscope head and replaceable tubes and is fully dismantlable. It is made of medical grade stainless steel. The tracheal tube mounted on the bronchoscope head is inserted into the trachea. The bronchial tube mounted on the bronchoscope head is inserted through the trachea into the bronchi. A telescope and instruments for diagnosis and treatment can be inserted through these tubes into the bronchi (bronchial tube) or the trachea, respectively. To ventilate the patient, the ventilation tube can be connected either to the bronchoscope head or directly to the respective tube. The tubes are colour coded depending on the size and have a scale to measure stenosis. DUTAU-NOVATECH® is supplied unsterile and must be cleaned, disinfected, and sterilized prior to its use.

I am sorry, but the provided text does not contain the detailed information required to fill out the table and answer all the questions comprehensively. The document primarily focuses on establishing substantial equivalence to a predicate device, listing the device description, intended use, indications for use, and a side-by-side comparison of technological characteristics.

Specifically, the following information is not present in the provided text:

• Acceptance Criteria for specific performance metrics (beyond general statements of meeting standards or passing internal protocols).
• Reported Device Performance against explicit acceptance criteria with quantitative results.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details or effect sizes.
• Standalone (algorithm only) performance study details.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document mainly discusses physical and mechanical performance tests for safety and functionality, such as disconnect stability, assembling, compression, tensile, connection stability, plug-in connection, luer lock connection, separation tensile force, atraumatic design, rotational torque, and leakage tests. However, it does not provide specific numerical acceptance criteria or quantitative results for these tests in a format that could be readily presented in the requested table.

The text confirms that "The test results have been checked against the requirements stated in the relevant standard or against the performance of the predicate device," and that "The requirements are fulfilled for all the test samples." This indicates successful testing but lacks the specifics requested.

Ask a specific question about this device