(179 days)
The Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff are intended for use in providing tracheal access for airway management.
The subject devices are single use; single cannula tracheostomy tubes that are intended to provide an artificial airway for airway management. The new features on the subject devices include a new plasticizer, the addition of the TaperGuard cuff, and additional sizes.
This document is a 510(k) Pre-Market Notification for a medical device, which seeks to demonstrate that the new device is substantially equivalent to existing legally marketed predicate devices. It does not describe a study to prove the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this submission.
However, I can extract information related to product performance testing that serves a similar function to acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria/Test | Reported Device Performance (Conclusion) |
|---|---|
| Cuff Air Seal | Subject devices perform at least as well as the predicate and are substantially equivalent. |
| Cuff Fluid Seal | Subject devices perform at least as well as the predicate and are substantially equivalent. |
| Removal Force | Subject devices perform at least as well as the predicate and are substantially equivalent. |
| Cuff Pressure Mapping | Subject devices perform at least as well as the predicate and are substantially equivalent. |
| Biocompatibility | Met all biocompatibility requirements for its intended use (per ISO 10993-1:2009 for cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity implantation, chemical characterization, and risk assessment). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "product performance testing" was performed, implying a test set of devices, but the number of units or individual tests is not provided.
- Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Covidien, likely in their own facilities. It is not "data" in the sense of patient data, but rather device performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the tests are for physical device performance (e.g., seal integrity, biocompatibility), not for an AI algorithm's diagnostic or predictive capabilities. The "ground truth" would be the measured physical properties of the device.
4. Adjudication method for the test set:
- Not applicable. This concept is typically used in clinical or image-based studies to resolve discrepancies in expert interpretations. For physical device testing, the results are objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, a MRMC comparative effectiveness study was not done. This device is not an AI/algorithm and does not involve human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical tracheostomy tube, not an algorithm.
7. The type of ground truth used:
- For the performance tests (cuff air seal, fluid seal, removal force, cuff pressure mapping), the "ground truth" is based on objective physical measurements and engineering standards.
- For biocompatibility, the "ground truth" is adherence to ISO 10993-1:2009 standards based on specific laboratory tests.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
Study Proving Acceptance Criteria:
The document states: "Product performance testing, including cuff air seal, cuff fluid seal, removal force, and cuff pressure mapping, were performed with the conclusion that the subject devices can be expected to perform at least as well as the predicate and can be considered substantially equivalent. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The device met all biocompatibility requirements for its intended use."
This paragraph serves as the summary of the studies conducted. While the specific methodology, number of repetitions, or detailed results are not provided in this summary, it confirms that tests were performed to demonstrate that the new device's performance characteristics are comparable to the predicate devices and meet established safety standards (biocompatibility). The 510(k) process relies on demonstrating "substantial equivalence" rather than proving superiority or meeting a strict, predefined performance threshold for a novel AI device.
§ 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.