(266 days)
The Disposable Double Lumen Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.
The Disposable Double Lumen Endobronchial Tube is indicated for adults use only.
The Disposable Double Lumen Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.
The Disposable Double Lumen Endobronchial Tube is consisted with double lumen tube with the body including 2 cuffs (Bronchial Cuff and Tracheal Cuff).
The tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, the bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. It is fitted with a stylet to enable shaping of the tube for navigation during intubation. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 8Fr or 10Fr with PVC and this device is packaged with two suction catheters.
The Disposable Double Lumen Endobronchial Tube comes in three models, each model include two types: Ordinary Left Type, Ordinary Right Type, Visible Left Type B, Visible Right Type B, Visible Left Type, Visible Right Type. Each type will be available in six sizes: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr and 41 Fr.
The device is composed of biologically safe materials. It is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery. The Disposable Double Lumen Endobronchial Tube is indicated for adults use only. Environments of use: Hospital-OR and ICU.
The provided text is a 510(k) summary for a medical device (Disposable Double Lumen Endobronchial Tube) and focuses on non-clinical performance testing and biocompatibility. It does not describe a study involving an AI algorithm or human readers.
Therefore, many of the requested details about acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set, effect size of AI assistance) are not applicable to this document.
The document primarily describes non-clinical performance testing to demonstrate functional and material equivalence to a predicate device.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance (Non-Clinical)
The submission provides a table of non-clinical performance test items, their reference standards, acceptance criteria, and reported test results.
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Performance Test Items | Reference Standards | Acceptance Criteria | Test Result |
|---|---|---|---|---|
| 1 | Dimensions | ISO 5361:2016 / ISO 16628:2008 | When tested in accordance with the test method, the L1, L2, L3, OD, ID shall meet the requirements on size and tolerances. | Pass |
| 2 | Inflating tube O.D. & Angle | ISO 5361:2016 | Inflating tube O.D.≤3.0mm; The angle between the inflating tube and the Endobronchial Tube at the point of separation shall not exceed 45°. | Pass |
| 3 | Cuff seal (Sealing of cuff inflating system) | / | When tested in accordance with the test method, no bubble shall be noted over the 10-s interval. | Pass |
| 4 | Cuffed tube collapse | ISO 5361:2016 | When tested in accordance with the test method in ISO 5361 Annex C, the steel ball shall pass freely through the lumen of the tube. | Pass |
| 5 | Cuff herniation | ISO 5361:2016 | When tested in accordance with the test method in ISO 5361 Annex D, no part of the inflated cuff shall reach beyond the nearest edge of the bevel. | Pass |
| 6 | Cuff Resting Diameter | ISO 5361:2016 | When tested in accordance with the test method in ISO 5361 Annex B, at a pressure of 2 kPa, the cuff diameter shall meet the requirements on size and tolerances. | Pass |
| 7 | Air leakage of one way valve | / | When tested according to the test method, the pilot balloon should be able to naturally fill up and flat deflate. | Pass |
| 8 | Liquid leakage of one way valve | ISO 80369-7:2021 | When tested in accordance with the test method, there shall be no leakage sufficient to form a falling drop of water. | Pass |
| 9 | Size of the Murphy Eye | ISO 5361:2016 | The area of the Murphy eye shall be not less than 80 % of the cross-sectional area derived from the minimum inside diameter for that size tube. | Pass |
| 10 | Security of Construction of connection components | / | When tested in accordance with the test method, the force required to detach any component permanently attached to the shaft shall be not less than that specified in standard. | Pass |
| 11 | 15mm connector | ISO5356-1:2004 | When tested in accordance with the test method, 15mm conical connectors shall comply with the ISO5356-1. | Pass |
| 12 | Colour Coding | ISO16628:2008 | When tested in accordance with the test method, the color coding of bronchial cuff and its pilot balloon were entirely coloured blue. | Pass |
| 13 | Segment differentiation of the tracheal segment and the bronchial segments | ISO16628:2008 | When tested in accordance with the test method, the segment differentiation of the tracheal segment and the bronchial segments were clearly distinguished. | Pass |
| 14 | Test for balloon diameter to inflation pressure | ISO10555-4:2013 | When tested in accordance with the test method, can reflect the relationship between balloon diameter and inflation pressure. | Pass |
| 15 | Cuff thickness | / | When tested in accordance with the test method, the cuff thickness shall meet the requirements on size and tolerances. | Pass |
| 15 | Cuff burst pressure | / | When tested in accordance with the test method, the burst pressure of the cuff shall meet the RBP 30kPa. | Pass |
Biocompatibility Testing:
The biocompatibility evaluation was conducted based on the device's classification as a surface device in contact with mucosal membrane for limited exposure (
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).