(25 days)
The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "O2n Demand-II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-II (OCPR-II)". This letter primarily addresses the administrative details of the clearance: correcting a product code.
It does not contain information about acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.
The document only states the "Indications For Use": "The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247)."
Therefore, I cannot provide a response that includes the requested information based on the provided text. The document is an FDA clearance letter and not a study report or clinical trial summary.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).