(78 days)
THE MICROSTREAM FILTERLINE OR/EMS DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO2 IN AN INTUBATED PATIENT'S BREATHING.
The common product name for our accessory is a gas sampling tube. The gas sampling tube is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a male Luer lock at one end of the device for connecting to the airway adapter in the ventilator or anesthesia machine airway and a female Luer lock on the other end for connecting to the capnograph. The two connectors are joined by a plastic tube and an in line hydrophobic filter. One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation. The most common way (for intubated patients) to connect the sampling tube to a point where it can get a sample of the patients breathing is to connect one end of the sample tube to a point on the ventilator or anesthesia machine airway circuit. The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The Microstream Filterline OR/EM has integrated an in line hydrophobic filter between the patient and the Capnograph to reduce the amount of patient generated moisture that can enter the capnograph.
The provided text is related to a 510(k) premarket notification for a medical device called "Microstream Filterline OR/EMS". This document describes the device, its intended use, and its substantial equivalence to a previously approved device. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for performance metrics of a device or algorithm.
The document is a regulatory submission for premarket clearance, which is focused on demonstrating substantial equivalence to a predicate device, not necessarily on detailing performance studies with specific statistical outcomes against acceptance criteria.
Therefore, I cannot provide the requested information in the format specified because the provided text does not contain it. The concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as outlined in the prompt (e.g., in terms of sensitivity, specificity, or improvement with AI assistance) is not present in this regulatory document, which focuses on device description and regulatory clearance.
The document's purpose is to get the device approved for market based on its similarity to an already approved device, rather than to present detailed performance study results that would typically include acceptance criteria tables, sample sizes, ground truth establishment, or AI-related metrics.
§ 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).