(97 days)
Ambu Disposable Pressure Manometer will be used to provide visual indication of the patient's airway pressure and may be attached to the manometer port on venting bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Ambu, Incorporated, for their "Ambu Disposable Pressure Manometer". This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other administrative aspects, but it does not detail:
- Acceptance criteria for device performance.
- Results of a study proving the device meets acceptance criteria.
- Sample sizes, data provenance, expert numbers/qualifications, or adjudication methods for test sets.
- Information on MRMC studies, standalone algorithm performance, or ground truth types.
- Training set details or ground truth establishment for a training set.
This type of information would typically be found in the 510(k) submission itself (which is not provided), or in a separate study report or technical documentation that supports the submission. The letter only serves as an approval of the device's substantial equivalence.
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).