(122 days)
The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.
The Altera Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line which is provided in 3 different lengths: 2, 2.5, and 3 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends.
The gas sampling line connects from a port in a circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the sampling port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are in the host device, which pull the gas from the sampling port to the host device for gas monitoring.
This document is a 510(k) premarket notification for a medical device, specifically "Altera Gas Sampling Lines." It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness through extensive clinical trials as might be seen for novel technologies or higher-risk devices.
Based on the provided text, the device is a simple, single-use, disposable component (a gas sampling line) that connects a breathing circuit to an expired gas monitor. There is no evidence in this document of AI or machine learning components, nor any mention of a study involving human readers improving with AI assistance. Therefore, the questions related to AI performance, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this submission.
Here's an analysis of the provided information concerning the acceptance criteria and the study that proves the device meets them, primarily focusing on the device's physical and functional performance, as that is the scope of this 510(k).
Acceptance Criteria and Device Performance for Altera Gas Sampling Lines
Given the nature of this device (a gas sampling line), the "acceptance criteria" are primarily related to its physical and functional performance characteristics, ensuring it performs its intended function (transporting gas samples) safely and effectively, and equivalently to the predicate device. The "study" proving this involves various non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
The table below summarizes the key performance attributes tested and the results presented in the document. The general acceptance criterion for these tests is that the proposed device (Altera GSL) performs comparably or better than the predicate device (Vyaire Vital Signs) and meets relevant industry standards.
| Acceptance Criteria (Attribute) | Predicate (Vyaire Vital Signs) Performance (Reference/Value) | Proposed (Altera GSL) Performance (Reference/Value) | Comparison |
|---|---|---|---|
| Classification | CCK - Carbon Dioxide Gas Analyzer, 21 CFR 868.1400 | CCK - Carbon Dioxide Gas Analyzer, 21 CFR 868.1400 | Same |
| Indications for Use | Connects from a port in the breathing circuit to the expired gas monitor. Used with specific GE Healthcare monitors. | Connects from a port in the breathing circuit to the expired gas monitor. | Similar |
| Principle of Operation | Gas pulled from one end of the tube to the other by a pump in the gas sampling device. | Gas pulled from one end of the tube to the other by a pump in the gas sampling device. | Similar |
| Patient Population | Any patient population requiring gas monitoring. | Any patient population requiring gas monitoring. | Similar |
| Environments of Use | Hospitals. | Hospitals, sub-acute, pre-hospital. | Similar |
| Compatibility | Designed for specific GE Healthcare modules. | Designed for use with any gas monitoring device with luer connections. | Similar |
| Single patient use, disposable | Yes. | Yes. | Similar |
| Materials | ISO 10993 tested, Co-extruded PE/EVA/PVC. | ISO 10993 tested, Co-extruded PE/EVA/PVC. | Similar |
| Flow Resistance | ~26 cmH2O @ 150 ml/min. | ~12 - 17.5 cmH2O @ 150 ml/min. | Similar |
| Leakage (per ISO 80601-2-55) | 35 Newtons. | >35 Newtons. | Similar |
| Leakage of Connectors | 0.02-0.05 ml/min. |
§ 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).