(141 days)
The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.
The provided document is a 510(k) summary for the Well Lead Tracheostomy Tubes, which was cleared in 2005. It describes the device, its intended use, and its equivalence to a predicate device.
However, the document does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance through a clinical or performance study involving human readers or algorithmic standalone performance. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies for safety and effectiveness.
Here’s a breakdown of the information requested, based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 5366-1 and ISO 5366-3) | Reported Device Performance |
|---|---|
| Conformance to ISO 5366-1 (Dimensions, Design, Material, Sterility, Packaging) | The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1. |
| Conformance to ISO 5366-3 (Dimensions, Design, Material, Sterility, Packaging) | The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-3. |
| Appropriate hardness of the tube | The tracheostomy tubes have such good performances as the tube with appropriate hardness. |
| Big capacity and low pressure cuff | The tracheostomy tubes have such good performances as the cuff with big capacity and low pressure. |
| Smooth tube | The tracheostomy tubes have such good performances as smooth tube. |
| Excellent biocompatibility | The tracheostomy tubes have such good performances as excellent biocompatibility. |
| Same dimensions and design as predicate device (Rusch Tracheofix Set) | The device has the same dimensions and design as the predicate device (Section 9 – not provided in the excerpt). |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. This submission does not describe a clinical performance study with a test set of data. The performance claims are based on conformance to international standards (ISO 5366-1 and ISO 5366-3) and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. See above. Ground truth, in the context of clinical studies for AI/algorithms, is not relevant to this type of device submission which focuses on physical and material specifications.
4. Adjudication method for the test set
- Not applicable / Not provided. See above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is a physical medical instrument (tracheostomy tube), not an AI/software-as-a-medical-device (SaMD) that would assist human readers or perform diagnostic interpretations.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. For this type of device, "ground truth" would relate to its physical and material properties meeting specified engineering and biocompatibility standards rather than diagnostic accuracy. The provided text indicates conformance to ISO standards and biocompatibility.
8. The sample size for the training set
- Not applicable / Not provided. This submission does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This submission does not involve an AI algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is primarily an engineering and materials conformance study against established international standards and comparison to a predicate device, rather than a clinical trial or an AI performance study.
The document states:
"The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3."
Additionally, claims are made about "good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility."
Finally, "The device has the same dimensions and design as the predicate device (Section 9)."
This implies that the manufacturer conducted internal testing and verification to ensure their device met the physical, material, and performance specifications outlined in the ISO standards and matched the predicate device’s characteristics. The FDA's 510(k) clearance is a determination of "substantial equivalence" based on this documentation, verifying that the new device is as safe and effective as a legally marketed predicate 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.