(230 days)
The H & H Emergency Cricothyrotomy (cuffed) Tube is indicated for emergency airway access when conventional endotracheal intubation cannot be performed. It is intended for adult patients for use in the following environments: Hospital Operating Room, Intensive Care Unit, the Emergency Room or out of the Hospital. This device is intended for Limited Duration Use (
The H & H Emergency Cricothyrotomy Tube is a sterile, single-use cuffed cricothyrotomy tube (airway tube) designed to provide an emergency airway to the patient's lungs when the upper airway/larynx/pharynx or oral & nasal routes are occluded or compromised due to traumatic injury. The outer diameter of the airway tube is 8mm and the inner diameter is 6mm. The inflatable cuff on the airway tube provides a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the airway tube and not allowed to escape into the patient's upper airway, thus preventing loss of ventilation as well as protecting against aspiration of stomach contents, blood, and body fluid. The airway tube incorporates a PVC flange 8cm from the distal end, which serves as a positive stop and prevents over insertion of the airwav tube and thereby minimizes the likelihood of right main stem bronchial intubation.
The provided information describes a K123528 510(k) submission for the "H & H Emergency Cricothyrotomy Tube (cuffed)". This is a medical device and not an AI/ML algorithm, therefore, many of the typical questions for AI/ML device studies are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed through non-clinical testing against established standards.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Connector Bonding Strength | Must be able to sustain axial force of $15 \pm 1.5N$ without movement | Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012") |
| Flange (neck-plate) Bonding Strength | Must be able to sustain axial force of $15 \pm 1.5N$ without movement | Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012") |
| Connector Fit Test | The connector's leading edge shall lie between the min and max diam steps of the gauge | Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012") |
| Biocompatibility Testing | Must meet requirements outlined in ISO 10993-1 and specified by FDA. | Met requirements (implied by "device met all requirements/clauses of ISO 5366-1:2012") |
| Functionality, Packaging, Sterilization, Shelf-life | N/A (General design requirements) | Met all design requirements |
2. Sample Size Used for the Test Set and Data Provenance
This is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "test set" with data provenance (country of origin, retrospective/prospective) doesn't directly apply in the same way. The testing involved physical samples of the manufactured device. The document does not specify the exact number of units tested for each non-clinical test, but it is implied that a sufficient number was tested to demonstrate compliance with the standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for physical device testing is established by engineering standards and specifications, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data, which is not relevant here.
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 a physical medical device, not an AI/ML algorithm. No human readers or AI assistance are involved in its primary function or testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on engineering standards and specifications. For instance, the "axial force" for bonding strength is a predefined physical parameter. Biocompatibility is assessed against ISO 10993-1 which provides methodologies and acceptance criteria for biological evaluation.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm; thus, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.