(265 days)
The Endoscopy Oxygen Mask is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.
The Endoscopy Oxygen Mask is a multi-port mask that serves several functions: A standard oxygen mask for when a patient requires supplemental oxygen; Sampling of exhaled gases for monitoring, typically end-tidal CO2; Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.
The provided document describes the Endoscopy Oxygen Mask (K220533) and its substantial equivalence to a predicate device, the Panoramic Oxygen Mask (POM) (K172365). The acceptance criteria for the new device are primarily demonstrated through comparative non-clinical testing against the predicate device, showing similar performance in key aspects.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each performance metric. Instead, it relies on demonstrating similarity or equivalence to the legally marketed predicate device (K172365) through non-clinical comparative testing. The performance is reported in terms of this similarity.
| Acceptance Criteria (Inferred from Comparison to Predicate) | Reported Device Performance (Endoscopy Oxygen Mask) |
|---|---|
| Indications for Use: Single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes for non-intubated, spontaneously breathing patients > 30 kg. | Similar to predicate. |
| Patient Population: Non-intubated spontaneously breathing patients (Adults to Children). | Similar to predicate. (Note: Subject device tested for Adults, whereas predicate was for Adults to Children). |
| Environment of Use: Locations where procedures are performed where the patient requires supplemental oxygen, monitoring exhaled gases, and scope access (Hospital, sub-acute, clinic, physician offices, pre-hospital). | Similar to predicate. |
| Duration of Use: Single patient, disposable, |
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).