(219 days)
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).
The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.
The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.
The mainstream gas analyzers are characterized by the following features:
- Low system integration complexity
- Low power consumption
- Fast startup time
- Low weight
The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.
Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.
However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.
1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):
| Parameter | Medical Gas Analyzer (AG200) Reported Performance | Predicate Device (K123043) | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| CO2 Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | Within ±(0.2 vol% + 2% of reading) for 0 to 15 vol% |
| N2O Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | Within ±(2 vol% + 2% of reading) for 0 to 100 vol% |
| Halothane, Enflurane, Isoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 8 vol% |
| Sevoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 10 vol% |
| Desflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 22 vol% |
| CO2 Accuracy (all conditions) | ±(0.3 vol% + 4% of reading) | ±(0.3 vol% + 4% of reading) | Within ±(0.3 vol% + 4% of reading) |
| N2O Accuracy (all conditions) | ±(2 vol% + 5% of reading) | ±(2 vol% + 5% of reading) | Within ±(2 vol% + 5% of reading) |
| Agents Accuracy (all conditions) | ±(0.2 vol% + 10% of reading) | ±(0.2 vol% + 10% of reading) | Within ±(0.2 vol% + 10% of reading) |
| Respiration Rate Range | 0 to 150 breaths/min | 2 to 150 breaths/min | 0 to 150 breaths/min (implied by compliance with ISO 80601-2-55 despite difference in predicate's lower limit) |
| Respiration Rate Accuracy | ±1 breaths/min | ±1 breaths/min | Within ±1 breaths/min |
| Anaesthetic Agents Threshold | 0.2 vol% | 0.15 vol% (with caveats) | 0.2 vol% deemed acceptable as verified by bench test and compliance with ISO 80601-2-55. |
| Warm-up time | 10-180 seconds |
§ 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).