(84 days)
Manually-controlled oxygen delivery system used for transtracheal ventilation.
The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. These systems are used in conjunction with a transtracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.
Manually-controlled oxygen delivery system used for transtracheal ventilation.
The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. These systems are used in conjunction with a transtracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.
The provided text is a 510(k) clearance letter from the FDA for a Manual Jet Ventilator (K991785). This document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are not novel.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
In a 510(k) submission for a device like a manual jet ventilator, the focus is typically on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety and effectiveness. This often involves:
- Comparison to a Predicate Device: A detailed comparison of the new device's design, materials, performance, labeling, and other relevant characteristics to a legally marketed predicate device.
- Performance Testing (Bench Testing): This would likely include tests to ensure the device meets its own design specifications (e.g., oxygen flow rates, pressure delivery, valve function, material biocompatibility, sterile packaging integrity if applicable). However, the specific acceptance criteria and detailed results of such tests are not present in this summary letter.
- No Clinical Studies: For a Class II device like this, especially when demonstrating substantial equivalence to a well-established predicate, clinical studies are often not required. The letter confirms this by stating equivalence to legally marketed predicate devices without mentioning clinical data.
To answer your request, based only on the provided text, I can state:
- No information on acceptance criteria or a specific study proving device meets acceptance criteria is provided in this FDA 510(k) clearance letter.
- The letter describes the Manual Jet Ventilator's intended use as a "manually-controlled oxygen delivery system used for transtracheal ventilation" in "specific emergency situations of upper airway obstructions."
Therefore, I cannot populate the table or provide the requested details because the source document does not contain this information.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).