Search Results
Found 1 results
510(k) Data Aggregation
(47 days)
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.
| Acceptance Criteria Category | Specific Tests/Criteria | Reported Device Performance |
|---|---|---|
| Material/Design | Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Similar to predicate, met ISO 10993 testing requirements for skin contact (limited duration < 24 hours). The gas sampling line is exhaust only with no gas flow back to the patient. |
| Mechanical/Physical | Age testing | Performed equivalent to the predicate. |
| Mechanical testing | Performed equivalent to the predicate. | |
| Luer Fitting | Meets ISO 80369-7. (Predicate used ISO 594-2, but subject device meets the updated standard) | |
| Flow / leaks | Meets ISO 80601-2-55. (Referred to as "Back pressure (Resistance to flow)" in the subject device's testing) | |
| Strength of bonds | Performed equivalent to the predicate. (Referred to as "Bond strength (Tensile strength of connections)" in the subject device's testing) | |
| Tensile Strength | Performed equivalent to the predicate. (Referred to as "Bond strength (Tensile strength of connections)" in the subject device's testing) | |
| Functional Equivalence | Indications for Use | Similar to predicate, both monitor exhaled gases. |
| Environment of Use | Identical to predicate (hospital, sub-acute, pre-hospital). | |
| Patient Population | Similar to predicate (pediatrics to adults/neonates). | |
| Duration of Use | Similar to predicate (single patient, disposable, less than 24h). | |
| Prescriptive | Similar; both are prescription devices. | |
| Mode of Operation | Similar (conduit from patient interface to monitor). | |
| Gas sampling connection | Similar (Luer slip fit or luer lock). | |
| Sampling tubing specs | Subject device IDs (1.0 & 1.5 mm) fall within range of predicate (1.10 mm) and reference (1.27 mm & 1.524 mm). Lengths differ but are generally comparable as sample lines. | |
| Materials | Similar (PVC tubing, Polypropylene/ABS connectors). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the non-clinical testing (test set) or any specific data provenance beyond the general statement that testing was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a passive accessory (CO2 sampling line) and does not involve subjective interpretation or diagnosis by experts to establish a "ground truth" as would be the case for an AI-powered diagnostic device. Its performance is measured against engineering standards and functional equivalence.
4. Adjudication Method for the Test Set
Not applicable. There is no "ground truth" established by experts that would require an adjudication method for this type of device. Performance is determined by objective physical and functional tests against industry standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This letter is for a CO2 sampling line, which is a physical accessory, not an AI-powered medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is established through objective engineering standards and performance specifications (e.g., ISO 80369-7 for luer fittings, ISO 80601-2-55 for flow/leaks, and ISO 10993 for biocompatibility) and comparative functional equivalence to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML or algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set.
Ask a specific question about this device
Page 1 of 1