(54 days)
The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer and components of these kits that allow for tracheal access for airway management for use in adults only.
The Portex "Ultra Perc" single use Percutaneous Dilation Tracheostomy Kits allow the percutaneous insertion of the Police Sublic Fere "Single discriptions of the stage) circumferencial dilatational Seldinger guidewire technique. Kits are supplied with a Portex Blue Line Ultra Tracheostomy Tube and introducer. The kits are intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel. A minimum of 2 operators are required - one to maintain the patient's airway, anaesthesia, breathing and circulation, and the other to perform the procedure. The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra The Forex Forealizer, are available in sizes 7.0, 8.0 and 9.0mm only.
The provided text is a 510(k) summary for a medical device (Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit). It aims to demonstrate substantial equivalence to previously marketed predicate devices, not primarily to prove device performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, for many of the requested points, the information is not present in the provided document. This is typical for a 510(k) submission that relies on substantial equivalence rather than new clinical effectiveness trials.
Here's an analysis based on the provided text, addressing each point where possible:
Acceptance Criteria and Device Performance Study for Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit
The provided document does not contain explicit acceptance criteria in the typical sense of numerical thresholds for a new clinical study. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Safety: Device is as safe as predicate devices. | The device is intended for use in environments like an Intensive Care Unit or operating room with trained personnel (minimum 2 operators). No specific safety metrics or quantified performance against safety criteria are provided, as substantial equivalence to predicate devices (already marketed and presumed safe) is asserted. |
| Effectiveness: Device is as effective as predicate devices for its intended use. | Intended Use: To create a percutaneous dilatational tracheostomy using guidewire dilators and components of the kit for tracheal access for airway management in adults. This is equivalent to the predicate devices. |
| Technological Characteristics: Similar in design, materials, and operating principle, or any differences do not raise new questions of safety or effectiveness. | The proposed device is stated to be equivalent to predicate devices in "all aspects except for the following: Tracheostomy tube Introducer." The curvature and materials of the Introducer will be compared with the Single Stage Dilator of Predicate 2 and the obturator of Predicate 3. The handle will be compared to the Single Stage Dilator of Predicate 2 and the Obturator/Introducer of Predicate 4. These comparisons are implied to demonstrate equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Performance data for the proposed device is shown in section 8.0 Performance. Clinical data is provided in Appendix 2." However, Section 8.0 and Appendix 2 are not provided in the excerpt. Therefore, the sample size or provenance of any direct test data for the proposed device is unknown from the given text.
The primary "evidence" for this 510(k) is based on the equivalence to predicate devices which have established clinical use. This is not a study that uses a "test set" in the traditional sense of a clinical trial for a novel device.
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-established ground truth for a test set. The focus is on demonstrating substantial equivalence to predicate devices, which are already in clinical practice.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.
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 device is a medical kit for a surgical procedure, not a diagnostic AI device. Therefore, an MRMC study and effects on human readers are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in a 510(k) submission based on substantial equivalence is the safety and effectiveness profile of the predicate devices as established by their prior marketing and clinical use. No new ground truth needed to be established for the proposed device, beyond demonstrating its similarity to these predicates.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.