(162 days)
The device is intended for use in providing tracheal access for airway management.
The subject devices are single patient use tracheostomy tubes that are intended to provide an artificial airway for airway management. It is available in multiple neonatal and pediatric sizes, all of which are available either cuffless or with a TaperGuard™ cuff. The products have a radiopaque tube with a clear flange and standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. The products are not made with natural rubber latex or DEHP.
The provided text is a 510(k) summary for a medical device, the Shiley™ Neonatal/Pediatric Tracheostomy Tube. It details the device's characteristics, intended use, and comparisons to predicate devices, along with the performance testing conducted to demonstrate substantial equivalence.
However, the document specifically states "N/A - Clinical evidence was not necessary to show substantial equivalence." This means that the submission did not include a clinical study in the traditional sense, especially not one involving human subjects that would typically require the establishment of an AI model's performance against human readers or a ground truth derived from expert consensus or pathology for a diagnostic or AI-driven device.
Therefore, many of the requested elements for AI model evaluation (like multi-reader multi-case studies, expert adjudication, training set details, etc.) are not applicable to this 510(k) submission as it concerns a physical medical device (tracheostomy tube) and not an AI/software device.
I can, however, extract information regarding the acceptance criteria and the studies that were performed to prove the device met those criteria for this type of medical device.
Acceptance Criteria and Device Performance for the Shiley™ Neonatal/Pediatric Tracheostomy Tube
This 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (tracheostomy tube) to existing predicate devices based on design, materials, and performance through non-clinical testing. It does not involve an AI model or diagnostic performance evaluation that would necessitate clinical studies, multi-reader analyses, or expert ground truth establishment in the way described in the prompt's questions.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria (Tests Performed) and Reported Device Performance:
| Acceptance Criteria (Test Category) | Specific Tests/Standards (Implicit Acceptance Criteria: Compliance) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Acute Systemic Toxicity, Genotoxicity, Subchronic Toxicity, Material Mediated Rabbit Pyrogen, Implantation, Chemical Characterization, Risk Assessment (in accordance with ISO-10993 and FDA Guidance) | Conducted and found acceptable (implicitly means device meets biological safety requirements). |
| Sterilization & Packaging Validation | Sterility (ISO 11135-1, ISO 10993-7), Packaging Integrity (ISO 11607-1) | Validation conducted to ensure sterility and packaging integrity are acceptable. |
| MRI Compatibility | MRI Safety and Compatibility, MR Compatibility Labeling (FDA guidance, ASTM F2503-13) | Product designated MR Conditional (cuffed) and MR Safe (cuffless), indicating successful testing compliance. |
| Bench Testing (Functional Performance) | ISO 5366-3, ISO 5356-1, Internal bench testing for cuff performance, connector mechanical performance, and cannula bend. | Testing conducted in accordance with specified ISO standards and internal protocols (implicitly means device meets functional requirements). |
| Design/Material Equivalence | Intended Use, Patient Population, Environment of Use, Single Patient Use, Sterilization Method, Shelf Life, Device Design to ISO standards, Size Range, Flange design, Connector design, Cannula Angle, Cannula Wall, Radiopaque Cannula, Cuff Type, Inflation System, Obturator & Neck Strap, Material composition (PVC, ABS, Polypropylene, Cotton). | Subject device demonstrated to be identical or equivalent (with explained changes like one-piece flange/connector and non-DEHP PVC material changes) to predicate devices on all listed parameters. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test, but standard for medical device bench testing and biocompatibility involves a sufficient number of samples to ensure statistical validity and representativeness of the manufacturing process. These are typically small, controlled batches for verification.
- Data Provenance: Laboratory test results from internal or contracted testing facilities for the subject device. These are prospective tests performed specifically for this 510(k) submission, not retrospective patient data. The country of origin for the testing itself is not specified, but the applicant (Covidien) is based in Boulder, CO, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- N/A. The testing conducted for this device is physical and material performance testing, not a diagnostic or AI evaluation requiring expert-established ground truth from clinical images or patient data. The "ground truth" here is compliance with engineering specifications, material standards, and regulatory guidelines, verified by laboratory measurements.
4. Adjudication Method for the Test Set:
- N/A. This concept applies to human reader studies or AI performance evaluations, not to the bench and material testing performed for this device. Test results are objective measurements against pre-defined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. As explicitly stated in the summary, "N/A - Clinical evidence was not necessary to show substantial equivalence." An MRMC study is a type of clinical study used for diagnostic devices, particularly those involving image interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- No. This device is a physical tracheostomy tube, not a software algorithm.
7. The Type of Ground Truth Used:
- For this device, the "ground truth" is defined by engineering specifications, international consensus standards (e.g., ISO 10993, ISO 11135, ISO 11607, ISO 5366, ISO 5356), and FDA guidance documents. Compliance with these established objective criteria serves as the basis for performance evaluation and substantial equivalence determination.
8. The Sample Size for the Training Set:
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As no training set for an AI model was used, this question is not applicable.
§ 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.