(66 days)
To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the EMT-CPAP device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily:
- Confirms that the FDA has reviewed the premarket notification (K021520) for the EMT-CPAP.
- Determines the device to be substantially equivalent to legally marketed predicate devices.
- Outlines the regulatory class (Class II) and product codes (BTL and BYE).
- Informs the manufacturer of their responsibilities under the Federal Food, Drug, and Cosmetic Act (e.g., registration, listing, good manufacturing practice, labeling).
- States the Indications For Use: "To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments."
Therefore, I cannot fulfill the request to provide details about acceptance criteria, study methodologies, or performance statistics based on the given document. This information would typically be found in the 510(k) submission itself, not in the FDA's clearance letter.
§ 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).