(352 days)
Intended use The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor).
Indications The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.
The CO2 Mainstream Sensor is designed for continuous, non-invasive mainstream measurement of Carbon Dioxide. The sensor is able to monitor CO2 using an infrared absorption technique and measures end tidal CO2 and inspired CO2 and calculates the respiratory rate. The data are processed by a microcontroller and provided to the parent device via a serial interface.
The sensor is adapted to the breathing system by airway adapters (CO2 measuring cuvettes).
Here's a summary of the acceptance criteria and study information for the CO2 Mainstream Sensor, based on the provided FDA 510(k) premarket notification:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics of the CO2 Mainstream Sensor with corresponding reported values in a consolidated format. However, it mentions extensive testing against various standards, which imply certain performance criteria. The key performance-related mention is the "Measuring range," which has been slightly extended compared to the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance |
|---|---|---|
| Measuring range | 0 to 13.2 Vol.%, 0 to 13.3 kPa, 0 to 100 mmHg | 0 to 15.8 Vol% (at 1013 hPa), 0 to 16.0 kPa, 0 to 120 mmHg |
| Respiratory Rate Range | 0 to 150 /min | 0 to 150 /min |
| Operating Temperature | -20 to +50 °C (-4 to 122 °F) | -20 to +50 °C (-4 to 122 °F) |
| Operating Humidity | 5 to 95 %, non-condensing | 5 to 95 %, non-condensing |
| Operating Ambient Air Pressure | 57 - 110 kPa (K100941) / 570 to 1100 hPa (428 to 825 mmHg) | 570 to 1100 hPa (428 to 825 mmHg) |
| Protection against penetrating liquids | IP64 | IP64 |
| Electrical Safety | Conformance to IEC 60601-1-6, IEC 60601-1-12 | Tested and Conforms |
| EMC | Conformance to IEC 60601-1-2, IEC/TR 60601-4-2 | Tested and Conforms |
| Biocompatibility | Conformance to ANSI AAMI ISO 10993-1 | Tested and Conforms |
| Software | Conformance to ANSI AAMI IEC 62304 | Tested and Conforms |
| Usability | Conformance to IEC 60601-1-6, AAMI / ANSI / IEC 62366-1 | Tested and Conforms |
| Risk Management | Conformance to ANSI AAMI ISO 14971 | Tested and Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for specific performance tests or studies like clinical trials in terms of the number of patients or specific data points. The testing mentioned is primarily bench testing and in vitro evaluations against technical standards and requirements.
The data provenance is not specified beyond indicating "extensive testing" and "well-established methods." It's reasonable to infer these tests were conducted by the manufacturer (Drägerwerk AG & Co. KGaA) in Germany, given the submitter's location. The studies appear to be retrospective in nature, drawing from the predicate device's established performance and applying new testing to demonstrate equivalence or improvement.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for testing in the context you describe (e.g., radiologists for image interpretation). The testing conducted is primarily objective, technical verification and validation against pre-defined standards and specifications for a CO2 sensor. Therefore, the "ground truth" for the test set would be derived from:
- Reference gases with known concentrations for CO2 measurements.
- Calibrated instruments for temperature, humidity, pressure, and electrical measurements.
- Standardized test procedures and benchmarks for software, EMC, and safety.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned, as this type of human expert consensus is not typically applicable to the kind of technical and bench testing described for this device. Test results would be compared directly to the specified standards and requirements.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. The CO2 Mainstream Sensor is a measurement device where its output is directly read rather than interpreted by multiple human readers in a comparative setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be primarily standalone performance testing, focusing on the algorithm (implicitly, the sensor's measurement principle and data processing) and hardware of the device itself. The "Discussion of Non-clinical Testing" section lists various technical evaluations, including software, electrical safety, EMC, and specific performance requirements from ISO 80601-2-55 for respiratory gas monitors. These are conducted on the device's inherent capabilities without human intervention for interpretation as part of the performance evaluation.
7. The Type of Ground Truth Used
The ground truth used for the technical testing would be:
- Reference Standards: Such as known concentrations of CO2 for accuracy testing, established environmental conditions (temperature, humidity, pressure), and defined electrical safety limits.
- Calibration Standards: High-precision instruments used to calibrate and verify the accuracy of the sensor's measurements.
- Compliance to Standards: The device's performance is measured against predefined thresholds and specifications outlined in the various IEC and ISO standards listed (e.g., ISO 80601-2-55 specific requirements for respiratory gas monitors).
8. The Sample Size for the Training Set
This device appears to be based on an established measurement principle (infrared absorption), and the submission focuses on demonstrating substantial equivalence through non-clinical testing rather than development of a novel algorithm that would require a "training set" in the machine learning sense. Therefore, there is no mention of a training set sample size as it's not applicable to the development verification of this type of device.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" mentioned in the context of machine learning, this question is not applicable to the information provided. The principles the device operates on are well-understood physics, and the validation relies on meeting established technical specifications and standards rather than learning from a dataset.
§ 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).