(196 days)
The CO2 Sample Lines are intended to be used where exhaled gas is monitored. The intended population: Patients requiring expired gas monitoring, adult to pediatrics. The intended environment of use: Hospital-OR, sub-acute, and pre-hospital settings.
Breath gas analysis is commonly performed to provide informatin related to a patient's condition. An example of a gas analysis often performed is capnography using an analyzer called a capnograph. Capnography is the monitoring of the time dependent respirary carbon dioxide(CO2) concentration, which may be used to directly monitor the inhaled and exhaled concentration of CO2, and indirectly monitor the CO2 concentration in a patient's blood. CO2 monitoring of patients respired gases can be used to display of information about CO2 production, pulmonary(lung) perfusion, alveolar ventilation (alveoli are hollow cavities in the lungs in which gas exchange is being performed) and respiratory patterns related to a patient's condition during anesthesia. In breath analysis systems, for example capnograraphy, breath gas can be sampled either by a mainstream or a sidestream analyzer. CO2 Sampling Lines are availabe for CQ2 sampling when mainstream capnography is used, so as to perform a mainstream capnographic measurement of the level of CO2. The CO2 Sampling Line is a sterile, disposable, singlie patient use cannula that allows sampling of patients exhaled gases. It consists of flexible extruded plastic tubes with standard connectors on each end. The cannula is a straight and flexible tube which permits the passage of a fluid such as carbon dioxide through an orifice (a buccal or nasal cavity of a patient). In addition, the CO2 sampling line is adapted used to connect between the patient's end of the breathing system and the distant analyzer, such as the capnograph monitor, along this tube, the patient's breath is continuously sampled.
The provided text is a 510(k) premarket notification for a medical device: a CO2 Sampling Line. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or the performance of a novel AI algorithm. Therefore, the document primarily describes non-clinical performance testing of the physical CO2 Sampling Line device itself, not an AI model.
Many of the requested details about acceptance criteria for AI models, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone AI performance, are not applicable to this type of device submission. The device is a physical medical instrument, not an AI or software as a medical device (SaMD).
However, I can extract the acceptance criteria and performance data that are relevant to this physical device based on the provided text.
Acceptance Criteria and Device Performance for CO2 Sampling Line
The device under review is a CO2 Sampling Line, a physical medical instrument. The acceptance criteria and performance are related to its physical and material properties, rather than the performance of an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implicit from "meets all pre-determined criteria" and comparison to predicate) | Reported Device Performance |
|---|---|---|---|
| General Performance | Dimensions | (Met pre-determined criteria) | Met |
| Back Pressure (flow rates) | Maximum back pressure |
§ 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).