(258 days)
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery, in Emergency Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a monitoring system during anesthesia/recovery in host Emergencv Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control.
The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module'smemory.
The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy.
The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.
The differences between the Capno M and M+ are only with the intended patient type. The Capno M is intended for use on intubated patients, where the Capno M+ is intended for use with intubated and non-intubated patients. The operating principles, unit of measurement, ETCO2 measurement range, accuracy, respiration rate range, and respiration rate accuracy are the same for both devices.
The CO2 Mainstream Module (Capno-M and Capno-M+) is a device intended to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care. The device's performance was evaluated through non-clinical studies covering electrical safety, electromagnetic compatibility (EMC), and specific performance criteria in accordance with ISO 80601-2-55. No clinical studies were performed.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Element of Comparison | Acceptance Criteria (Predicate Device K042601) | Reported Device Performance (Subject Device) | Discussion/Compliance |
|---|---|---|---|
| CO2 Response Time | Mainstream: 80 bpm, all ranges are ±12% of actual) | ||
| Respiration Rate Measure Range | 2~150 breaths/minute (RPM) | 3 - 150 breaths/minute (RPM) | 2 RPM respiration rate is abnormal. Minimum not critical. Complies with ISO80601-2-55. |
| Respiration Rate Accuracy | ±1 breath per minute | ±1% of reading or ±1 breaths/min (whichever is greater) | Both devices have the same accuracy. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each performance test. The document refers to "bench testing for Inspired CO2 range and accuracy, and Respiration rate range and accuracy." This implies laboratory testing on a device unit or units.
- Data Provenance: The tests conducted appear to be non-clinical bench tests performed by the manufacturer, Beijing Kingst Commercial & Trade Co., Ltd., to demonstrate compliance with international standards. No information regarding country of origin for the data or whether it was retrospective or prospective is provided, as it is non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for the performance tests (e.g., CO2 concentration, respiration rate) would have been established by calibrated laboratory equipment and reference gases/controlled conditions as per the ISO 80601-2-55 standard, not by human expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this involves non-clinical bench testing for performance and safety, human adjudication methods like 2+1 or 3+1 are not used. Compliance is typically determined by directly comparing device output to known inputs and standard requirements.
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:
- No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a CO2 mainstream module, which is a sensor for measuring carbon dioxide, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance data presented is for the device operating as a standalone sensor (without human interpretation or assistance as part of the primary measurement function). The device's accuracy and range in measuring CO2 and respiration rate are intrinsic to the device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For CO2 and respiration rate measurements, the ground truth would be established through calibrated reference standards and controlled experimental conditions as specified by the relevant testing standards (e.g., ISO 80601-2-55). This involves using known concentrations of CO2 gases and controlled airflow patterns to simulate breathing.
8. The sample size for the training set:
- Not applicable. This device is a hardware sensor, not a machine learning or AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of 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).