(78 days)
The Microstream Filterline ICU 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 an in line hydrophobic filter and an in line Nafion (K881264A) moisture membrane tube.
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 information provided is a 510(k) premarket notification for a medical device called "Microstream Filterline ICU." This document focuses on establishing substantial equivalence to a predicate device and does not contain acceptance criteria, a detailed study description with performance metrics, or information typically found in a clinical validation study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.
The document states:
- Intended Use: To conduct a sample of the patient's breathing from a ventilator or anesthesia machine airway to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation.
- Device Description: A gas sampling tube with a Male Luer Lock for connecting to an airway adapter and a Female Luer Lock for connecting to a Capnograph. It includes an in-line hydrophobic filter and an in-line Nafion moisture membrane tube.
- Substantial Equivalence: The Microstream ICU Filterline is "identical to the same device described as an accessory to the NPB-75/Microcap Capnograph/Pulse Oximeter in approved submittal K964239."
Conclusion:
This submission is a premarket notification asserting substantial equivalence, leveraging the prior approval of an identical device (K964239). It does not present new performance data from a specific study to meet acceptance criteria. The FDA's review confirms this substantial equivalence based on the provided information, not on a new, independent performance study with defined acceptance criteria and results.
§ 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).