(279 days)
The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
The Well lead Tracheostomy Tubes and Disposable Inner Cannula includes an outer cannula, disposable inner cannula, introducer, neck strap and obturator. The disposable inner cannula acts as a removable liner for the outer tube; it can be withdrawn and changed after the airway has been cleaned, such as phlegm suction. The disposable inner cannula facilitates the airway management to make it easy to clean and prolong the use of the device. The device is used to provide an artificial airway in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by the means of the swivel neck plate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation.
The provided text describes a 510(k) summary for the Well Lead Tracheostomy Tubes and Disposable Inner Cannula. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, innovative device.
Instead, the submission demonstrates that the new device has the same intended use and similar technological characteristics as the predicate device (K042684). Therefore, the "acceptance criteria" here refer to demonstrating this equivalence through adherence to relevant standards and a comparative analysis of features.
Here's a breakdown based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
For this specific submission, the "acceptance criteria" are not quantitative performance metrics but rather qualitative conformity to established standards and similarity to a predicate device.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (as presented) |
|---|---|
| Same Intended Use as Predicate Device (Well Lead Tracheostomy Tubes, K042684) | "The proposed device is substantial equivalent to the Well Lead Tracheostomy Tubes, which has been cleared under K042684. The proposed device has the same intended use..." |
| "The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients." (Same as predicate) | |
| Similar Technological Characteristics to Predicate Device | "The proposed device... and similar technological characteristics as compared to the predicate device." |
| "Both Well Lead Tracheostomy Tubes and Disposable Inner Cannula and Well Lead Tracheostomy Tube have the same intended use, there is no new indications or contraindications." | |
| "Both the modified and unmodified device include an outer cannula, introducer, neck strap. A disposable inner cannula and obturator are being added to the modified device, both devices continue to have cuffed and uncuffed versions." | |
| Conformity to relevant International Standards (ISO 5366-1 and 5366-2 for dimension, design, material, sterility and packaging of tracheostomy tubes) | "The dimension, design, material, sterility and packaging of Well Lead Tracheostomy Tubes and Disposable Inner Cannula conform to ISO 5366-1 and 5366-2." |
| No new indications or contraindications | "there is no new indications or contraindications." |
| Maintain safety and effectiveness | "Well Lead Medical Instruments Ltd has demonstrated that Well Lead Tracheostomy Tubes and Disposable Cannula is safe and effective." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a substantial equivalence submission, not a clinical performance study with a test set of patient data. The "testing" mentioned refers to engineering and quality assurance tests demonstrating conformity to ISO standards, not tests on a clinical population. Therefore, there is no sample size for a test set or data provenance in terms of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert readers to establish a ground truth for a test set. The evaluation is based on technical specifications and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there is no test set in the clinical sense, there is no adjudication method.
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. This is not a study involving AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument (tracheostomy tube), not an algorithm or AI-powered system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the existing predicate device and the accepted international standards for such devices. The new device demonstrates conformance to these standards and equivalence to the predicate.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-driven device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.