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510(k) Data Aggregation
(287 days)
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
The Nasal CO2 Sample Line is intended to be used to sample exhaled gas.
The O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.
The Oral / Nasal CO2 Sampling Cannula is intended to be used where exhaled gas is monitored.
The O2 Delivery with Oral / Nasal CO2 Sampling Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.
The Divided O2 Delivery / CO2 Sampling Nasal Cannula is intended to be used where low flow oxygen is administered and exhaled gas is monitored.
The Sample Lines are intended to be used where exhaled gas is monitored.
Environment of use - hospital, sub-acute, and pre-hospital settings.
Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.
The devices are non-sterile, disposable, single patient use cannulas and sample lines intended for sampling exhaled gases and/or delivering supplemental oxygen. Specific descriptions for each device type are provided: Nasal CO2 Sample Line, O2 Delivery / CO2 Sampling Nasal Cannula, Oral / Nasal CO2 Sampling Cannula, O2 Delivery with Oral / Nasal CO2 Sampling Cannula, Divided O2 Delivery / CO2 Sampling Nasal Cannula, and Sample Lines.
This document describes the equivalence of several CO2 sampling cannulas and lines (referred to as "Modified ETCO2 Devices") to previously cleared predicate devices. The primary change in the new devices is the material formulation.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Predicate Specifications) | Reported Device Performance (Modified ETCO2 Devices) |
|---|---|---|
| Back Pressure | Shall not have a back pressure that exceeds 3 psi at a maximum flow rate in ambient temperatures of 5°C, 20°C, and 40°C. | Maximum back pressure was found to be less than 2 psi. |
| Bond Strength | The bonded components of the set will have a bond strength that is ≥ 2 lbs. when pulled at a rate of 5 inches per minute. | The bond strength test achieved over 2 times the minimum allowable value. |
| Device Dimensions | Unchanged from predicate devices. | Unchanged (use the same molds as predicate devices). |
| Biocompatibility | (Implicit: Must meet biocompatibility standards for medical devices) | Passed all parameters: Irritation, Sensitization, Cytotoxicity, Particulate, Volatile organic compounds. |
| Shelf Life | None (for predicate devices listed) | 3 years (performance testing after simulated 3-year aging was performed). |
2. Sample sized used for the test set and the data provenance:
The document does not specify the exact sample sizes used for the performance tests (back pressure, bond strength, biocompatibility). It states "The test results demonstrate that the device is substantially equivalent" and "The materials passed all parameters" without providing numerical sample sizes.
The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Salter Labs for FDA clearance in the USA. The tests appear to be prospective in nature, performed on the newly modified devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" here is based on quantifiable engineering and material performance standards (e.g., specific psi for back pressure, lbs for bond strength, and established biocompatibility testing protocols), not expert interpretation of clinical data or images.
4. Adjudication method for the test set:
Not applicable. This is a technical performance study, not a study requiring adjudication of human interpretation.
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 document describes material and mechanical performance testing of a medical device (CO2 sampling cannibal/line), not an AI algorithm or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is not about an algorithm.
7. The type of ground truth used:
The ground truth used for this study is based on engineering specifications and established material safety standards.
- For back pressure and bond strength, the ground truth is the numerical threshold values (e.g.,
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