(318 days)
The OC-FLEX® Flexible IntraOral Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
The OC-FLEX® Flexible IntraOral Cannula is a disposable, non-sterile, single use device that is intended to provide a means for sampling exhaled gases from a patient (i.e., end-tidal CO2) with the option to simultaneously or independently deliver supplemental gas therapy (i.e., O2).
The device design consists of dual, conjoined PVC tubing united by an end cap providing two separate gas pathways. One portion of the tubing is dedicated to supplying gas from a gas source to the patient as required by the prescribed therapy. The other portion of the tubing is dedicated to the sampling of exhaled gas from the patient to a gas analyzer (i.e., a capnograph) for end-tidal CO2 monitoring. The design of the OC-FLEX® Flexible IntraOral Cannula incorporates a flexible wire located inside a separate, dedicated lumen in the gas supply tubing in conjunction with an end cap comprised of a filter. The flexible wire feature of the cannula is isolated from the delivery gas as well as the exhaled gas in a dedicated lumen within the gas supply tubing. This allows customizable positioning of the cannula for delivery and sampling of gas. This design is engineered to provide the practitioner flexibility and mobility during the procedure. The end cap minimizes occlusion during sampling of exhaled gas and segregates the gas sampling from the supplied gas for therapy to the patient. This design feature allows the delivery of the prescribed gas (i.e., oxygen) to the oral cavity. The end cap design features a 3-micron hydrophobic filter, which prevents the transfer of water vapor or other body fluid from the patient down to the monitoring line and into the gas sampling equipment.
The OC-FLEX® Flexible IntraOral Cannula is a single patient device, designed for use by one patient over a single course of treatment. The device is available with either a male luer connector or female luer connector. The device is supplied in a sealed poly bag in a non-sterile state and is not to be sterilized.
Here's a breakdown of the acceptance criteria and study information for the OC-FLEX® Flexible IntraOral Cannula, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| End-tidal CO2 values | End-tidal CO2 values shall not be statistically different (or vary less from the true end-tidal CO2 values) than the predicate device. | The end-tidal CO2 values for the OC-FLEX® Flexible IntraOral Cannula were not statistically different, or varied less from the true end-tidal CO2 values, than the predicate product. A comparison of variances of the end-tidal CO2 measurements from the actual values for the two devices indicates that the OC-FLEX® Flexible IntraOral Cannula has the least variance from true value when compared to the predicate device, within 95% confidence intervals. |
The OC-FLEX® Flexible IntraOral Cannula also underwent other non-clinical testing with the following results:
- Biocompatibility Testing: Successfully completed ISO 10993 testing (Cytotoxicity, Sensitization, Intracutaneous Irritation) with no incidence of cytotoxicity, sensitization, or intracutaneous irritation.
- Volatile Organic Compound (VOC) Testing: All identified compounds demonstrated levels within available recommended limits (using EPA methodology).
- Particulate Matter Testing: Particulate matter results demonstrated levels below recommended limits (using NIOSH methodology).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The performance test involved a total of 36 tests. This was derived from (3 samples x 3 respiratory settings x 4 oxygen flow rates). Specifically, for each combination of respiratory setting (8, 16, 25 bpm) and oxygen flow rate (0, 1, 3, 6 LPM), three measurements were taken.
- Data Provenance: This was a bench study using a Harvard Respiratory pump and a mannequin head. Therefore, the data is synthetic/simulated and not from human subjects or a specific country of origin in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not explicitly state the number of experts or their qualifications for establishing the "true end-tidal CO2 values" for the bench testing. The "true end-tidal CO2 values" are implied to be the controlled input values of 5% end-tidal concentration set on the simulation apparatus.
4. Adjudication Method for the Test Set
- The document does not mention an adjudication method for the test set. The results were based on direct measurement and statistical comparison to the predetermined "true" end-tidal CO2 values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This was a bench study comparing the device's performance against a predicate device and controlled "true" values. There were no human readers involved in interpreting the results from the device in a clinical context.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Yes, a standalone performance study was done. The described performance testing is a standalone evaluation of the device's ability to accurately measure end-tidal CO2 under various simulated conditions, without human intervention in the measurement process itself, other than setting up the experiment.
7. Type of Ground Truth Used
- The ground truth used was controlled, simulated values (e.g., 5% end-tidal concentration) set on a Harvard Respiratory pump and mannequin head apparatus. This represents an ideal, known "true" value in a controlled environment.
8. Sample Size for the Training Set
- The document does not mention a training set. This device is a physical medical device (cannula) and its performance was evaluated through physical bench testing, not through machine learning or AI models that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
- As there was no training set, this information is not applicable.
§ 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).