(70 days)
The 8400 Capnocheck II is a low cost CO2 monitor with pulse oximeter and optional external printer. It may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient ground transport, EMS (Emergency Medical Services) and anesthesia. The capnography parameter provides end tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements on all patients from pediatric to adult. The oximetry parameter works with all BCI oximetry sensors, providing %SpO2 and pulse rate on all patients from pediatric to adult. The 8400 Capnocheck II permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. It is not intended nor designed to be used as an apnea monitor.
The BCI 8400 Capnocheck II monitor performs capnography and pulse oximetry using the same technology as existing legally marketed devices. Capnography data includes end-tidal CO2 (ETCO2), inspired CO2 (inCO2), and respiration rate measurements as well as a respiration breath indicator and ETCO2 waveform. Oximetry data includes functional arterial blood oxygen saturation (%SpO2) and heart rate measurements as well as pulse strength indicator and plethysmogram. This device is designed to provide full-featured monitoring. capabilities in a lightweight, hand-held design. The system consists of a small hand held monitor with optional infrared linked printer and AC powered battery eliminator. Features include a gas inlet connection, an exhaust gas connection, an SpO2 sensor interface, Ilquid crystal display (LCD), system status LEDs, function keypad, and infrared serial port. The LCD display has an electroluminescent (EL) backlight and displays patient data, waveforms, trends, breath and pulse rate indicators, alarm limit indicators, and messages. The keypad consists of six keys: power, waveform/trend, alarm silence, up and down arrows, and menu/enter. There are three system status LEDs: alarm silence, high and medium/low priority alarms. The infrared serial port is used for data communication with the optional printer.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific, quantifiable acceptance criteria. The performance claims are framed as meeting existing standards and matching predicate device performance.
| Parameter/Criterion | Acceptance Criteria (Implicit from text) | Reported Device Performance |
|---|---|---|
| General Safety | Adherence to recognized medical device safety standards | "The monitor passes all of these tests and met all requirements of the standards (EN60601-1, Reviewer's Guidance for Respiratory Devices, 1993, and other international standards)." |
| Environmental Performance | Adherence to environmental guidelines and standards | "The results demonstrated that the BCI 8400 monitor complied with the guidelines and standards (Reviewer's Guidance for Respiratory Devices, 1993 and EN60601-1-2) and that it performed within its specifications and functional requirements." |
| Electromagnetic Compatibility (EMC) | Compliance with standards | Demonstrated compliance. |
| Electrical Safety | Compliance with standards | Demonstrated compliance. |
| Mechanical Durability | Compliance with standards | Demonstrated compliance. |
| Safety (Operator and Patient) | Compliance with standards | Demonstrated compliance. |
| Temperature/Humidity Performance | Compliance with standards | Demonstrated compliance. |
| Capnography (ETCO2, inCO2, Respiration Rate) | Performance within specifications, equivalence to predicate device. Adherence to EN 864. | "Testing of device performance included clinical testing of the ETCO2, respiration rate, and SpO2 measurements... Further performance testing of the capnography parameter was also conducted in accordance with EN 864... The results demonstrated that the BCI 8400 monitor performed within its specifications." |
| "Comparison testing... showed that the performance of the ETCO2, respiration rate... parameters of the two devices (BCI 8400 and BCI 9000) are the same. All measurements were within the specified tolerances of the monitors and simulators." | ||
| Pulse Oximetry (%SpO2, Heart Rate) | Performance within specifications, equivalence to predicate device | "Testing of device performance included clinical testing of the ... SpO2 measurements made by the BCI 8400 monitor... The results demonstrated that the BCI 8400 monitor performed within its specifications." |
| "Comparison testing... showed that the performance of the ... %SpO2, and heart rate parameters of the two devices (BCI 8400 and BCI 9000) are the same. All measurements were within the specified tolerances of the monitors and simulators." | ||
| Human Factors | Acceptable user interaction | "A human factors review... were performed to demonstrate overall device performance." (Implied satisfactory outcome) |
| Long Term Alarm Test | Acceptable long-term alarm functionality | "A long term alarm test were performed to demonstrate overall device performance." (Implied satisfactory outcome) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a numerical sample size for the clinical testing of ETCO2, respiration rate, and SpO2 measurements. It mentions "clinical testing" but provides no further details on the number of patients or measurement points. For the comparison testing using simulators, it states "The tests were run with simulator settings spanning the 8400's entire specification range," but again, no specific number of test points or simulator runs is provided.
- Data Provenance: Not explicitly stated. The company is based in Wisconsin, USA, but no specific country of origin for the "clinical testing" data is given. It is not specified if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies described are primarily technical and comparison testing against predicate devices or simulators, rather than studies requiring expert ground truth for interpretation (e.g., image analysis for pathology).
4. Adjudication Method for the Test Set:
This information is not provided as the studies are not described in a way that would necessitate an adjudication method among multiple experts. The comparison testing relies on instrument readings against known simulator settings or predicate device readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
An MRMC comparative effectiveness study was not done. This device (BCI Capnocheck II) is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a form of standalone performance assessment was done. The device's measurements (ETCO2, respiration rate, SpO2, heart rate) were directly compared against simulator settings and the measurements from predicate devices without human interpretation or intervention as part of the primary performance evaluation. The "clinical testing" mentioned also implies standalone performance of the device on patients, though no detailed results are given beyond "performed within its specifications."
7. The Type of Ground Truth Used:
- Instrument Ground Truth / Defined Standards: For the comparison testing, the "ground truth" was established by simulator settings and the performance of legally marketed predicate devices (BCI 9000 Capnograph/Oximeter).
- Compliance with Industry Standards: For general safety, environmental performance, and capnography parameters, adherence to international standards such as EN60601-1, EN864, and the Reviewer's Guidance for Respiratory Devices, 1993, served as a form of ground truth or benchmark.
8. The Sample Size for the Training Set:
This information is not applicable/provided. The BCI Capnocheck II monitor is described as utilizing "currently available technology found in many legally marketed devices" and does not appear to be an AI/machine learning device that would typically require a training set in the conventional sense. Its design and performance are validated through direct technical testing and comparison to existing, established predicate devices, not via a learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the same reasons stated in point 8.
§ 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).