(174 days)
To provide tracheal access for airway management.
These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck, which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.
This document describes the 510(k) submission for the Shiley Extended Length, Disposable Cannula, Tracheostomy Tube. The device is intended to provide an artificial airway for adults.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (CEN Standard Requirements) | Reported Device Performance (Modified Device Test Results) | Notes on Predicate Device Performance |
|---|---|---|---|
| Tie Strap Hole Strength | No requirement for this test parameter | 45.8 lbs force | 26.7 lbs force (SCT) |
| Outer cannula body to Trach Head Base Bond Strength | No requirement for this test parameter | 55.0 lbs force | 143.0 lbs force (SCT) |
| Trach Head Base-to-Head Cap Bond | No requirement for this test parameter | 90.5 lbs force | N/A |
| Cuff Burst Strength | No requirement for this test parameter | 6.6 lbs force | 8.3 lbs force (SCT) |
| 15mm Connector Disconnect Force | No requirement for this test parameter | 19.4 lbs force | 19.1 lbs force (SCT) |
| Neck Plate to Trach Tube Body Attachment Strength | minimum 11.3 lbs force | 27.7 lbs force | 42.1 lbs force (DCT) |
Summary of Device Performance against Acceptance Criteria:
- For tests with no specified CEN standard requirement, the device performance is reported without a direct "pass/fail" criterion. However, the performance is presented to demonstrate its physical integrity and generally favorable or comparable results to predicate devices.
- For the "Neck Plate to Trach Tube Body Attachment Strength" test, the modified device's performance (27.7 lbs force) exceeds the specified minimum CEN standard requirement (11.3 lbs force), thus meeting this acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for each "in-vitro performance data" test. It provides single values for "Modified Device Test Results" and "Predicate Device Test Results," implying these are representative or average values from testing, but the number of units tested is not specified.
- Data Provenance: The data is generated from in-vitro performance testing, meaning it was conducted in a laboratory setting. There is no information regarding country of origin of the data provided, nor whether it's retrospective or prospective, as it's not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: This study relies on in-vitro performance data for medical device mechanical properties, not expert-derived "ground truth" observations from cases (e.g., image interpretation). Therefore, no human experts were involved in establishing ground truth for the test set in the conventional sense of clinical or diagnostic studies.
4. Adjudication Method for the Test Set
- Not Applicable: As stated above, this is an in-vitro performance study focusing on physical integrity, not a study involving human interpretation or clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The study explicitly states: "Clinical data was not necessary, since device performance can be adequately assessed by in-vitro testing." Therefore, there is no effect size reported for human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a study on a physical medical device (tracheostomy tube), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here.
7. The Type of Ground Truth Used
- The "ground truth" for this study is based on objective measurements of physical and mechanical properties of the device (e.g., force, strength) in a laboratory setting, compared against established engineering standards (CEN Standard Requirements where applicable) or direct comparison to predicate device performance. It is an objective, quantifiable measurement of the device's physical integrity and functional parameters.
8. The Sample Size for the Training Set
- Not Applicable: This document describes a 510(k) submission for a physical medical device and its in-vitro performance. It does not involve machine learning or AI, and therefore there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As explained above, there is no training set for this type of device submission.
§ 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.