(130 days)
The FLOCAP is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
The FLOCAP has a visual indicator to visually detect the end of exhalation.
For use up to 24 hours.
For patients greater than 15 kg (33 lbs.)
Environment of use - hospital, sub-acute, pre-hospital, transport
The proposed FLOCAP is comprised of several components:
- Housing with standard 15 mm / 22 mm fittings to connect to ventilatory assist devices and a face . mask or endotracheal tube
- . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH
- . A spinner / vane which spins when there is expiratory flow. It is to detect presence of expiratory flow
The FLOCAP device, a colorimetric CO2 detector, was deemed substantially equivalent to the predicate device, Mercury Medical STAT CO2 (K021576), based on non-clinical performance testing and comparative specifications.
Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate: Mercury Medical STAT CO₂) | Reported Device Performance (FLOCAP) |
|---|---|---|
| Indications for Use | Semi-quantitative visualization of CO₂ in patient airway; adjunct in patient assessment. | Identical: Semi-quantitative visualization of CO₂ in patient airway; adjunct in patient assessment, with a visual indicator for end of exhalation. |
| Patient Use / Duration if use | Single patient use, disposable, 5.0% CO₂ - Permanent Yellow | 0% CO₂ - Purple; 1.0-2.0% CO₂ - Beige; > 5.0% CO₂ - Yellow (Different colors, but similar functionality of color change for CO₂ detection) |
| Method of Communicating Meaning of Color Changes | Matching Colored Label on the Outside of the device | Identical: Matching Colored Label on the Outside of the device |
| Meanings of detecting patient exhalation | Color change | Color change; Spinning vane - visual indicator (detects exhalation flow > 1 lpm) (Added feature, enhances detection) |
| Standards | ISO 5356-1 | ISO 5356-1, ISO 9360-1 HME in part (Adherence to relevant standards) |
| Filter element | Present | Not present (Considered not to raise new concerns as patient secretions mitigation is similar to predicate's instructions) |
| Pull tab to activate | Present | Not present (Packaging demonstrated safe storage without deterioration) |
Study Information
- Sample size used for the test set and the data provenance: Not explicitly stated for specific tests. The summary indicates "comparative specifications" and "specific tests related to the device" were performed. The testing seems to be bench testing against the predicate's specifications rather than a clinical study with a patient test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical ground truth establishment by experts is not described for the non-clinical performance testing.
- Adjudication method for the test set: Not applicable.
- 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: An MRMC comparative effectiveness study was not performed. This is a non-AI medical device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Standalone performance was assessed through various non-clinical bench tests (e.g., color change response time, leakage, minimum static flow indication, anti-fog, shelf-life, drop test, duration of use, burst pressure, compliance, pressure drop, internal volume, usability).
- The type of ground truth used: For the bench testing, the "ground truth" was established based on engineering specifications, physical measurements, and comparison to the predicate device's characteristics and performance parameters.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: 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).