(190 days)
Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.
The Shiley ™ Adult Flexible Tracheostomy Tube Cuffless is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial ainway in order to provide access to the patient's airway for airway management. It contains an integrated 15 mm connector for use with standard ventilation and anesthesia equipment. The tracheostomy tube has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. This tracheostomy tube can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff is a dual cannula tracheostomy tube with a disposable inner cannula. The device is used to provide an artificial airway in order to provide access to the patient's airway management. It contains an intecrated 15 mm connector for use with standard ventilation and anesthesia equipment. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff has a radiopaque outer cannula constructed of polyvinyl chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for easy inspection and allows for airway maintenance. The tracheostomy tube has a taper-shaped, low-pressure cuff to provide an effective air and fluid seal and minimize tracheal wall damage. The cuff inflation line has a luer valve with an integral pilot balloon. The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff can be used with or without the disposable inner cannula included in the package however, use of the inner cannula is recommended.
When inserted in a tracheotomy stoma, the device may be secured in place with a neck strap around the patient's neck which is attached to an integral neck plate. It also may be secured in place by using the suture holes in the flange of the tracheostomy tube, thereby providing for a secure artificial ainway for spontaneous breathing or direct connection to ventilation or anesthesia equipment.
The provided text describes a 510(k) premarket notification for new Shiley™ Adult Flexible Tracheostomy Tubes. It is an application for a medical device seeking a determination of substantial equivalence to a legally marketed predicate device, and thus often does not involve extensive clinical studies. The document primarily focuses on demonstrating that the new device is as safe and effective as existing ones through non-clinical data.
Because this is a 510(k) submission, the "acceptance criteria" discussed are typically related to meeting established standards and performance benchmarks analogous to the predicate devices, rather than achieving specific accuracy metrics in a clinical study. The study presented is non-clinical performance testing.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" as would be found in a clinical trial for diagnostic accuracy (e.g., target sensitivity/specificity). Instead, the performance requirements are implicit in meeting the ISO standards and demonstrating equivalent performance to predicate devices in various non-clinical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 5356-1:2004 (Conical connectors) | Achieved (Non-clinical testing performed) |
| Compliance with ISO 5366-1:2009 (Adult Tracheostomy Tubes) | Achieved (Non-clinical testing performed) |
| Compliance with ISO 5361:2012 (Tracheal tubes and connectors) | Achieved (Non-clinical testing performed) |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Genotoxicity, Subchronic toxicity implantation, Chemical characterization, Risk assessment) | Achieved (Non-clinical testing performed) |
| Adequate Cuff Pressure Mapping (for cuffed tubes) | Achieved (Performance testing performed) |
| Adequate Flange Tape Tie strength | Achieved (Performance testing performed) |
| No Air Leakage | Achieved (Performance testing performed) |
| Adequate Inflation Line Pull Strength | Achieved (Performance testing performed) |
| No Cuff Puncture & Adequate Air Seal | Achieved (Performance testing performed) |
| Smooth Insertion/Removal | Achieved (Performance testing performed) |
| Compatibility with Percutaneous Dilatational Tracheotomy (PDT) | Achieved (Performance testing performed, for relevant models) |
| Sterility Assurance Level (SAL) of 10^-6 | Achieved, "utilizing the existing equivalent validated cycle 2." |
| 2-year shelf life | Confirmed |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Non-Clinical Data" and lists various types of non-clinical testing. It also states "Clinical Data - Not required to show substantial equivalence."
Therefore:
- Sample Dize for Test Set: Not applicable in the context of human patients or medical images. The "test set" consisted of physical devices subjected to various engineering and biological safety tests. The specific number of devices tested for each non-clinical assessment is not detailed in this summary.
- Data Provenance: The data is from laboratory (non-clinical) testing conducted by Covidien. The country of origin for the data is not specified, but would typically be the location of the manufacturing and testing facilities. It is retrospective in the sense that the device was developed and then tested, but not "retrospective" as typically used for clinical data from past patient records.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For non-clinical tests, the "ground truth" is typically defined by standardized methods, specifications, and regulatory requirements (e.g., ISO standards), rather than expert consensus on patient data.
4. Adjudication Method
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data. For non-clinical, objective tests, results are typically determined by adherence to established protocols and measurement techniques.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Data - Not required to show substantial equivalence." This type of study would involve human readers (like radiologists) evaluating cases, which is clinical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical device (tracheostomy tube), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Compliance with recognized international standards: e.g., ISO 5356-1:2004, ISO 5366-1:2009, ISO 5361:2012.
- Performance specifications derived from predicate devices: The new device must perform comparably or better than the legally marketed predicate devices (Shiley™ Tracheostomy Tubes K962173 and Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes K963732).
- Established biological safety parameters: As defined by biocompatibility testing (cytotoxicity, sensitization, irritation, etc.).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
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.