(30 days)
The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns), KTP (532 nm) or Blue Laser (445mm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.
The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP, 445nm Blue Laser, or CO2 lasers. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.
This document is a 510(k) premarket notification for a modification to a medical device, specifically the Tenax® Laser Resistant Endotracheal Tube. It primarily addresses the addition of 445 nm Blue Laser compatibility to the device's indications for use.
Based on the provided text, here's information related to acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Laser resistance to CO2 (10.60 microns) | The device is designed with an inner aluminum scattering layer for laser resistance. (Implicitly met as it's a feature of both subject and predicate devices, and the modification adds Blue Laser compatibility, not removes CO2 capabilities). |
| Laser resistance to KTP (532 nm) | The device is designed with an inner aluminum scattering layer for laser resistance. (Implicitly met as it's a feature of both subject and predicate devices, and the modification adds Blue Laser compatibility, not removes KTP capabilities). |
| Laser resistance to Blue Laser (445 nm) | The performance data provided for "Laser resistance" supports the substantial equivalence of the modified device, implying it meets resistance for 445 nm Blue Laser. Specific numerical performance data is not detailed in this summary. |
| Atraumatic outer layer for patient tissue protection | The device has an atraumatic outer layer. (Feature shared with predicate). |
| Inflatable cuffs | The device has inflatable cuffs. (Feature shared with predicate). |
| Use of internal dye as a warning indicator | The device uses internal dye as a warning indicator. (Feature shared with predicate). |
| Overall safety (non-clinical) | Non-clinical data supports the safety of the device. |
| Performance as intended | Verification and validation testing demonstrate the device performs as intended. |
| Comparability to predicate | Data demonstrates the Tenax® Laser Resistant Endotracheal Tube performs comparably to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details about the sample size used for the test set of the laser resistance testing. It simply states "Laser resistance" as performance data.
The document does not specify data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This document is a regulatory submission for a medical device (endotracheal tube) and focuses on engineering/performance testing, not on clinical interpretation or AI model accuracy that would require expert-established ground truth. Therefore, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
This document is a regulatory submission for a medical device (endotracheal tube) and focuses on engineering/performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving expert reviews of diagnostic images/interpretations. This information is not applicable and not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe a multi-reader multi-case comparative effectiveness study. This type of study is relevant for AI-driven diagnostic tools, not for a physical medical device like an endotracheal tube.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This document does not describe a standalone algorithm performance study. This type of study is relevant for AI-driven diagnostic tools, not for a physical medical device like an endotracheal tube.
7. Type of Ground Truth Used
The "ground truth" for this device's performance would be established through a combination of engineering specifications, material science testing, and laser interaction physics rather than expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices. The document mentions "verification and validation testing" which implies objective measurement against predefined technical requirements for laser resistance and other physical characteristics.
8. Sample Size for the Training Set
This document does not refer to a training set. The "Tenax® Laser Resistant Endotracheal Tube" is a physical medical device, not an AI/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this physical medical device.
§ 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).