(120 days)
Emergency airway access (when endotracheal intubation is not possible) by percutaneous insertion of a cricothyroidotomy tube through the cricothyroid membrane.
The new cricothyroidotomy kit is designed for introduction of an emergency 6mm cuffed airway tube through the cricothyroid membrane. The airway tube is provided pre-assembled onto a dilator with a Veress needle located in the centre. The kit employs two well-established and understood techniques: Firstly: The use of a Veress needle to provide visual indication of entry into a body cavity. (the trachea). (This can be confirmed by aspiration through the needle as with the predicate Cook Melker product ref. IFU in Attachment B(i)) The Veress needle is usually used for insufflation of the abdomen. It has a central sprung-loaded protective core to the needle that guards the cutting point and gives a visual indication via a "flag" at the hub end of the needle tip is passing through tissues. When the needle tip passes through into the abdominal cavity, or tractica, passure in ough assucer ------------------------------------------------------------------------------------------------------------------------------------------------------ Secondly: the use of a dilator/introducer to enlarge a stomal opening and place an airway tube within the traches. The pre-assembled needle/dilator/tube is inserted through the cricothyroid whill the tracether and the tube is then slid off the dilator fully into the trachea. This is the same principle employed by the Cook Melker Cricothyroidotomy sct. As well as the airway tube assembly, the kit provides the user with scalpel for skin incision, syringe for aspiration to confirm location of the needle in the trachea, sutures and neck-strap to secure the airway tube and a heat and moisture exchanger to reduce patient energy loss and protect the airway from blockage. These are all items that will be well understood by the user. Packaging comprises a rigid hinged blister pack for protection and a polythene/Tyvek welded pouch as the sterile barrier. pouch as ale sterilised and individually packed in a carton together with the directions for use.
The provided text is a 510(k) summary for the Portex Emergency Cricothyroidotomy Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study with quantitative metrics like sensitivity or specificity.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's a breakdown of why the requested information is absent based on the provided text:
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Table of acceptance criteria and reported device performance: Not present. The document focuses on comparing the new device's technical characteristics and indications for use to those of legally marketed predicate devices to establish substantial equivalence, not to demonstrate performance against pre-defined acceptance criteria.
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Sample sized used for the test set and data provenance: No test set or associated sample size is mentioned. Clinical studies to evaluate performance against acceptance criteria are not typically required for a 510(k) submission where substantial equivalence is being claimed. The document primarily describes the device and its operational principle.
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Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no test set or ground truth establishment is described.
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Adjudication method for the test set: Not applicable, as no test set or adjudication process is described.
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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 mechanical medical instrument, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance of AI or imaging interpretations.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established or discussed in the context of performance evaluation. The "ground truth" for a 510(k) in this context is typically the established safety and effectiveness of the predicate device.
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The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided 510(k) text is a regulatory document seeking market clearance based on substantial equivalence to existing devices. It does not include the detailed performance study information requested, which would be typical for a PMA submission or a de novo classification, or for devices with novel technology requiring specific quantitative performance metrics.
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).