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The CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient.
Environment of use – hospital, sub-acute, and pre-hospital settings.
Patient population – Patients requiring expired gas monitoring.

Barbaras Development Inc. CO2 Sampling lines are the accessories in breathing system and intended for sampling of exhaled gases for monitoring, typically end-tidal CO2.

The Barbaras Development Inc. CO2 sampling lines are 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 gas sampling is exhaust only and there is no gas flow back to patient.

The Barbaras Development Inc. CO2 Sampling Lines are a disposable, single patient use that allow to sample of patients exhaled gases. It consists of flexible extruded plastic tubes with and standard connectors on each end. We will present several different configurations like have the filter or without filter in the middle which have been tested and compared to predicates.

The Barbaras Development Inc. CO2 Sampling Lines are offered in the following models: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line.

Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling line are connected to the monitor via a standard luer fitting, whether it is a female or male fitting.

The provided FDA 510(k) clearance letter details the clearance of CO2 Sampling lines manufactured by Barbaras Development Inc. The clearance is based on substantial equivalence to a predicate device, Tylenol Medical Instruments Co., Ltd - K181981 - CO2 sampling line, and a reference device, ProMedic – Gas Sampling Lines – K023579.

It's important to note that this document is a 510(k) summary for a medical device that is an accessory (CO2 sampling lines) and not an AI/ML powered diagnostic or prognostic tool. Therefore, many of the requested elements, such as MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details, are not applicable to this type of device and are not present in the provided text. The evaluation focuses on physical characteristics, material compatibility, and basic performance parameters against established standards.

Here's the breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes "Non-Clinical Testing Summary" and "Performance testing" categories, indicating that these were the acceptance criteria for the device. The reported performance is generally stated as "performed equivalent to the predicate" and "All testing demonstrated that the subject devices are substantially equivalent to the predicate." No specific numerical results are provided in this summary.

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