(157 days)
The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.
The monitoring line tubing is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. When used with a face mask the line connects between the female luer lock connector on the mask and a capnograph or similar gas monitoring device. The gas monitoring device will have a pump which pulls air from inside mask, along the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Disclaimer: This document describes a medical device called "C02 Monitoring Line and C02 Monitoring Line with Filter." The "study" described is a submission for 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a clinical study establishing efficacy or a standalone algorithm performance study. Therefore, some of the requested categories (like MRMC studies, human reader improvement, and training set details) are not applicable or cannot be extracted from this type of regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds in this document, but rather implied by the comparison to a predicate device. The performance is reported by comparing the new device's characteristics to those of the predicate device (K946044). The "acceptance criteria" here implicitly mean that the new device's performance for these characteristics should be comparable or substantially equivalent to the predicate device to justify market clearance.
| Characteristic | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (CO2 Monitoring Line) | Reported Device Performance (CO2 Monitoring Line + Filter) | Predicate Device Performance (Gas Sampling Line, K946044) | Predicate Device Performance (Gas Sampling Line + Filter, K946044) |
|---|---|---|---|---|---|
| Intended Use | Same as predicate | Connect from C02 sampling port to expired gas monitor | Connect from C02 sampling port to expired gas monitor | Connect from port in face mask breathing circuit to expired gas monitor | Connect from port in face mask breathing circuit to expired gas monitor |
| Target Population | Same as predicate | Any patient from which gas monitoring is required | Any patient from which gas monitoring is required | Any patient from which gas monitoring is required | Any patient from which gas monitoring is required during the patient's breathing cycle |
| Where Used | Same as predicate | Hospitals | Hospitals | Hospitals | Hospitals |
| Single Use/Reusable | Same as predicate | Single Use | Single Use | Single Use | Single Use |
| Resistance to Flow | Comparable to predicate | 8.1mbar at 100ml/min flow; 20.7mbar at 300ml/min flow (for non-filter) | 26.3mbar at 100ml/min flow; 82.0mbar at 300ml/min flow (for filter) | 12.5mbar at 100ml/min flow; 35.9mbar at 300ml/min flow (for non-filter) | 14.6mbar at 100ml/min flow; 47.3mbar at 300ml/min flow (for filter) |
| Leakage |
§ 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).