(15 days)
The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula are intended to be placed into a surgical opening of the trachea to provide tracheal access for airway management. The device is intended to be a component of a life-sustaining device to be used with adult patients.
The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula includes an extended length outer cannula, extended length disposable inner cannula, tracheostomy tube holder, neck strap, and obturator. The device is used to provide an artificial airway, in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by means of the swivel neck plate/flange that is connected to a tracheostomy tube holder or neck strap. When appropriately connected to a tracheostomy tube holder or neck strap, the device provides a secure artificial airway for spontaneous or mechanical ventilation.
This 510(k) summary describes a Special 510(k) submission for the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. A Special 510(k) can be submitted when modifications to a legally marketed device do not require a new clinical study to demonstrate substantial equivalence. Instead, the submission relies on design control activities and verification testing to show that the modified device remains safe and effective for its intended use, similar to the predicate device.
Given that this is a Special 510(k) and the provided text focuses on the substantial equivalence to a predicate device based on design, materials, and technical characteristics, it does not contain the detailed study information typically found for devices requiring performance testing against acceptance criteria in a standalone study or a comparative clinical effectiveness study. The submission essentially states that the new device meets the same performance as the predicate due to similar design and materials, and that verification testing confirmed these aspects.
Therefore, the requested information elements related to specific performance studies, expert involvement, and ground truth establishment, as typically applied to novel devices or those undergoing significant functional changes, are not explicitly provided in this document.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. Instead, it states that:
- "Product design and development, (including verification testing, test and quality procedures) were conducted using internal company requirements, referencing external standards."
- "Information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use."
This implies that the device's performance was evaluated against internal design specifications and relevant standards, and found to be comparable to the predicate device. However, the specific quantitative acceptance criteria and results are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention a specific "test set" in the context of clinical data or a formal study with statistical sample sizes. The evaluation relies on "verification testing," which typically involves engineering and bench testing, rather than human subject testing in the sense of a clinical trial. Therefore, information about data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The submission focuses on device modifications and verification testing, not on a diagnostic or interpretive task that would require expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done. This type of study is typically performed for imaging or diagnostic AI devices to assess the impact of AI assistance on human reader performance. This device is a medical accessory, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study of an algorithm was done. This device does not inherently contain an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this type of device is established through engineering principles, material science, and conformance to recognized standards for medical devices of this class. It would involve demonstrating physical properties, biocompatibility, and functional integrity through various tests (e.g., tensile strength, flexibility, dimensions, leakage) to ensure it performs as intended and is safe. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. Sample Size for the Training Set:
Not applicable. This device does not involve machine learning or a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable due to the absence of a training set for an AI algorithm.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.