(230 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a cricothyrotomy tube, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
This device is designed to provide emergency airway access to the patient's lungs, which is a therapeutic intervention for compromised airways.
No
The device is a cricothyrotomy tube, an emergency airway device, not a diagnostic tool. Its purpose is to establish an airway, not to diagnose a condition.
No
The device description clearly describes a physical medical device (a cuffed cricothyrotomy tube) and its physical characteristics (outer diameter, inner diameter, cuff, flange). There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The H & H Emergency Cricothyrotomy Tube is a medical device used to establish an airway directly within the patient's body. It is a surgical/interventional device, not a diagnostic one.
- Intended Use: The intended use is for emergency airway access, which is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a device used for a medical procedure to manage a patient's airway, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The H & H Emergency Cricothyrotomy 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 (
§ 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.
0
JUL 0 3 2014
i
510(k) Summary
H & H Emergency Cricothvrotomy Tube (cuffed)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The FDA Group on behalf of: H & H Associates
CAGE 1NNH6 Ordinary, VA 23131
Paul Harder .
July 1, 2014
General Information
Submitter Name:
Address:
Contact Person: Date Prepared:
Device Name
Proprietary Name: Common Name: Classification Name: Device Class: Product Code: CFR Section:
Emergency Cricothyrotomy Tube Cricothvrotomy Tube Tracheostomy tube and tube cuff Class II ીଠାન 868.5800
Description
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.
Intended Use/Indications for Use
The H & H Emergency Cricothyrotomy 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 (