(221 days)
Indicated use - When a sample of a patient's expired gas is to be analyzed.
Targeted population - Any patient requiring monitoring of expired gases.
Environment of use - Hospital, anesthesia, ICU, PACU, respiratory therapy
The intended product is a small bore tube with luer fittings which permit a sample of patient's expired gas to be delivered to an analyzer. The device may be of various lengths, tubing diameters and have an in-line filter
The provided text describes a medical device (Gas Sampling Interface Kits) and compares it to a predicate device, but it does not contain information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the specific information you've asked for. The document focuses on establishing substantial equivalence to a predicate device based on intended use, design, materials, and generic performance testing (e.g., "Luer fittings: Yes" implies they perform as expected, but no specific metrics are given).
Here's an output demonstrating what I can extract and highlighting the missing information:
Description of Device: Gas Sampling Interface Kits (Disposable Gas Sampling Lines)
Intended Use: When a sample of a patient's expired gas is to be analyzed. Targeted population: Any patient requiring monitoring of expired gases. Environment of use: Hospital, anesthesia, ICU, PACU, respiratory therapy.
Predicate Device: Gibeck, Inc. - disposable gas sampling lines - K841722
Below is a table showing the available comparison points, but crucially, acceptance criteria and specific performance metrics are absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric Included in Document | Acceptance Criteria (Not specified) | Reported Device Performance (Implied by equivalence to predicate) |
|---|---|---|
| Use | ||
| Indicated for use with expired gas | N/A | Yes (Matches predicate) |
| Intended for use in anesthesia | N/A | Yes (Matches predicate) |
| Intended for use in respiratory therapy | N/A | Yes (Matches predicate) |
| Indicated for single use | N/A | Yes (Matches predicate) |
| Design | ||
| Luer fittings | N/A | Yes (Matches predicate) |
| Clear tubing | N/A | Yes (Matches predicate) |
| Various diameters of tubing | N/A | Yes (Matches predicate) |
| Various lengths of tubing | N/A | Yes (Matches predicate) |
| May be supplied with filter | N/A | Yes (Matches predicate) |
| Materials | ||
| Luers made of PVC, PC, ABS, Acrylic | N/A | Yes (Matches predicate) |
| Tubing - PVC, PE, PVC/PE | N/A | Yes (Matches predicate) |
| Performance Testing (General) | ||
| Luer fittings (Functionality) | N/A | Yes (Implied to be equivalent to predicate) |
Note: The document only states "Performance Testing: Luer fittings: Yes" without providing any specific criteria (e.g., leak rate, pressure resistance) or quantitative results. The acceptance criteria for any performance characteristic are not provided. The reported device performance is implicitly considered acceptable due to its equivalence to the predicate device.
Missing Information (Not available in the provided text):
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not mentioned; this document describes a traditional device comparison, not an AI efficacy study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable in the context of this device and the provided document. The "ground truth" here is the functional performance and material composition, which are tested against engineering specifications (not detailed here) and compared to the predicate.
8. The sample size for the training set: Not applicable; this is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable; this is a physical medical device, not an AI algorithm.
§ 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).