(200 days)
The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide. Environment of use - hospital and sub-acute settings. Patient population - Non-intubated patients who are breathing spontaneously.
The proposed Capnomask design is like a standard oxygeu mask with a port for connecting a gas sampling line which is then to be comected to a gas monitor to measure exhaled carbon dioxide. The mask has a connector which incorporates ports for connecting standard oxygen tubing and a luer fitting to counect a standard gas sampling line. In addition, it has air entrainment holes to supply room air if needed. It is available in sizes ranging from large to snuall, similar to the predicate device.
Here's a breakdown of the acceptance criteria and the study information for the Capnomask, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document defines substantial equivalence primarily by comparing the proposed device (Capnomask) to a predicate device (Capnoxygen LLC Capnoxygen mask K971229) across various attributes. The acceptance criteria are implicitly defined by the predicate's characteristics and performance, with the Capnomask demonstrating equivalence.
Here's a table summarizing the comparison, with performance essentially being "determined to be substantially equivalent" or "identical" to the predicate.
| Acceptance Criteria (Predicate) | Reported Device Performance (Capnomask) |
|---|---|
| Indications for Use: Deliver supplemental oxygen and monitor breathing by sampling exhaled CO2. | Identical: Intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide. (Discussion: Each device is indicated for use delivering supplemental oxygen and sampling expired gases.) |
| Environment of use: Hospitals and sub-acute setting. | Identical: Hospitals and sub-acute setting. (Discussion: The environments of use are identical to the predicate.) |
| Patient population: Non-intubated patients who are breathing spontaneously. | Identical: Non-intubated patients who are breathing spontaneously. (Discussion: The patient populations are identical to the predicate.) |
| Technology and construction (Design, fabrication, shape, size, etc.): Equivalent to predicate. | Equivalent: Demonstrated by dimensional verification, internal volume, entrainment port size, and configuration of the sampling connector. Minor dimension/volume differences not clinically significant due to non-airtight seal and entrainment holes. (Discussion: The design incorporates a standard face mask shape, connector for oxygen tubing and luer fitting for connecting a gas sampling line.) |
| Performance Testing (End-tidal CO2 results and waveform at various settings): Comparative results against predicate. | Substantially Equivalent: Comparative CO2-sampling and waveform performance at various breathing rates, tidal volumes, and oxygen flow rates. Noted dilution of EtCO2 at higher flow/breath rates, which is expected. (Device is a tool for qualitative detection of breathing and supplemental O2 delivery.) |
| Performance Testing (Real-time aging): Evaluation for performance to specifications (pressure drop and resistance). | Substantially Equivalent: Real-time aging performed and device evaluated for performance to specifications including pressure drop and resistance. |
| Performance Testing (Environmental and Mechanical testing): Successful completion. | Substantially Equivalent: Environmental and mechanical testing completed. |
| Materials (Biocompatibility): Compliance with ISO 10993 for surface (direct) and externally communicating (indirect) contact. | Compliant: ISO 10993 testing performed for Cytotoxicity, Sensitization, Intracutaneous Irritation, and Total VOC. |
Study Details
The document describes non-clinical testing performed to establish substantial equivalence.
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Sample size used for the test set and the data provenance:
- The document does not explicitly state a specific numerical sample size for the "test set" in terms of how many devices were tested or how many breathing cycles/scenarios were performed. The testing described is "at various breathing rates, tidal volumes, and oxygen flow rates."
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission seeking clearance in the US, these tests would typically be performed internally or by a contracted lab as pre-market validation studies. There's no mention of external clinical data or specific geographic origin for the test data itself (e.g., country of origin for the data). It is a retrospective evaluation of the device's technical and performance characteristics.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for the performance testing (CO2 sampling, pressure drop, etc.) would be established by validated test equipment and scientific measurements, not by expert human interpretation of medical images or observations. The comparison is against the predicate device's established performance, implicitly considered the benchmark.
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Adjudication method for the test set:
- Not applicable. This type of performance testing involves objective measurements rather than subjective human assessment requiring adjudication.
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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:
- No. This is a medical device (oxygen mask with CO2 sampling), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and AI-assisted improvements for human readers are irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm. It is a passive device (mask) with a port for sampling gas for an external monitor. Its performance is inherent in its design and ability to deliver oxygen and allow for accurate gas sampling, not in an independent algorithm.
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The type of ground truth used:
- For performance testing (CO2 sampling and waveform, pressure drop, resistance): The ground truth would be established by objective physical measurements using calibrated laboratory equipment and gas analyzers. The "truth" is what is measured by these instruments under controlled conditions. The comparison is then made against the predicate device's measured performance under similar conditions.
- For material biocompatibility: Standardized ISO 10993 biological evaluation tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Total VOC) serve as the ground truth for safety.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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).