(172 days)
The Pulmonx Visualized Endotracheal Tube (VETT) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation, for oral and nasal intubations.
The VETT System is indicated for viewing during difficult intubation procedures, for verifying tube placement and repositioning, for viewing during suctioning and for general inspection of the airway.
The Pulmonx Visualized Endotracheal Tube (VETT) with Cuff utilizes the fiberoptic components of a bronchoscope and integrates them into the wall of a standard endotracheal tube. Real-time endoscopic visualization from the distal end of the tracheal tube is possible on a continuous or intermittent basis without disconnecting the patient from the mechanical ventilator.
The VETT is made with biocompatible materials. The device is supplied with a preformed arc, pre-cut to length and with depth markings and a full length radiopaque stripe. The distal tip is a hooded bevel with a Murphy's eye. The cuff is a low pressure-high volume cuff. The inflation system has a self sealing valve. The airway connector is a standard 15mm connector. The device is sterilized by ethylene oxide and is designed for single use. The sizes are 7.0, 7.5 and 8.0 mm ID.
The VETT works in conjunction with the Pulmonx Compact Video System which includes a 5 inch LCD display, an integral Light Source and a Remote Handpiece and Cable. A Head Mounted Display is provided as a supplement to the primary display.
The Pulmonx Visualized Endotracheal Tube System (VETT) was evaluated for substantial equivalence to predicate devices. The study did not involve AI, human readers, or a multi-reader multi-case design.
Here's a breakdown of the acceptance criteria and performance based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|---|
| VETT Cannula Flexibility | Substantially equivalent force to conform to patient anatomy as the Mallinckrodt Medical Hi-Lo EndoTracheal Tube. | The force is "substantially equivalent" to the predicate Mallinckrodt Medical Hi-Lo EndoTracheal Tube. |
| VETT Cannula Lumen Patency | Pass the lumen patency test (e.g., by passing a steel ball (ASTM1242, A1.2)). | Passes the lumen patency test (by passing a steel ball (ASTM1242, A1.2)). |
| VETT Cuff Symmetry | Meets ASTM requirement. | Meets the ASTM requirement. |
| VETT Cuff Herniation | Meets ASTM requirement. | Meets the ASTM requirement. |
| VETT Cuff Compliance | Meets ASTM requirement. | Meets the ASTM requirement. |
| VETT Cuff Leak Resistance | Meets ASTM requirement (ASTM1242). | Meets the ASTM requirement. |
| VETT Cuff Tracheal Sealing Pressure | Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube. | Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube. |
| VETT Cuff Fatigue | Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube. | Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube. |
| VETT Cuff Burst Performance | Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube. | Meets or exceeds that of the Mallinckrodt Hi-Lo Tracheal Tube. |
| Biocompatibility | All applicable biocompatibility testing is acceptable. | All applicable biocompatibility testing is acceptable. |
| Fiberoptic System Image Quality | Good performance, substantially equivalent to predicate devices. | Good performance and "substantially equivalent" to the predicate devices. |
| Fiberoptic System Light Output | Good performance, substantially equivalent to predicate devices. | Good performance and "substantially equivalent" to the predicate devices. |
2. Sample Size and Data Provenance
The document does not explicitly state specific sample sizes for each test. Instead, it refers to "all samples" for the fiberoptic system testing. The provenance of the data is not specified; it is assumed to be internal testing conducted by Pulmonx, Inc. and not from clinical trials involving human subjects or external data sources. The study is a retrospective comparison against existing product specifications and performance characteristics of predicate devices.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This device utilizes objective physical and performance measurements (e.g., force, patency, ASTM standards) rather than expert interpretation of images or clinical data for establishing ground truth.
4. Adjudication Method
Not applicable. The evaluation is based on objective measurements and comparisons to established standards or predicate device specifications, not on subjective expert opinions requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a physical medical device, not an AI or imaging diagnostic tool.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The document describes various tests performed on the VETT cannula, cuff, and fiberoptic system to demonstrate its safety and effectiveness. These tests were conducted on the device itself (e.g., measuring forces, lumen patency, cuff properties, image quality, light output).
7. Type of Ground Truth Used
The ground truth used is primarily based on:
- Established Standards: ASTM1242 for lumen patency, cuff leak resistance, symmetry, herniation, and compliance.
- Predicate Device Specifications/Performance: Performance benchmarks set by the Mallinckrodt Medical Hi-Lo Tracheal Tube for cannula flexibility, minimum tracheal sealing pressure, fatigue, and burst performance, and by the Olympus LF1/LF2, American Optical LS-6A/LS-7, Welch Allyn Hi-Lux, and UroHealth END-101 for the fiberoptic and video system characteristics.
- Objective Measurements: Internal testing to quantify properties like image quality, light output, and force.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning system, and therefore does not have a "training set" in the conventional sense. The development of the device would have involved internal testing and iteration, but this is not reported as a formal training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an algorithm. The design and performance targets for the VETT were established based on the characteristics of existing predicate devices and relevant industry standards.
§ 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).