(212 days)
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
The Gas Module 3 is an independently powered unit capable of interfacing with Mindray DS USA, Inc. (hereafter MRDS) Patient Monitors using a proprietary communications protocol. The system connects to the patient monitor via a RS232 connector. All Gas Module 3 data display on the monitor screen. And all user commands are entered on the monitor and then electronically transmitted to the Gas Module 3.
The Gas Module 3 measures in real-time, breath-by-breath CO2, O2, N2O gases. Additionally, the Gas Module 3 monitors the anesthetic agents Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Desflurane (DES) and Enflurane (ENF).
The Gas Module 3 consists of AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board and Communication Board.
The subject device is a modified version of a previously cleared model, the Gas Module SE. The Gas Module SE was cleared under K062754, on September 13, 2006.
The provided text is a 510(k) summary for the "Gas Module 3" device (K180788). This document primarily focuses on establishing substantial equivalence to a predicate device (Gas Module SE, K062754) based on non-clinical testing. It does not describe an acceptance criteria study in the conventional sense of establishing performance against a predefined clinical or statistical threshold.
Instead, the study outlined is a series of non-clinical bench tests and EMC/Electrical Safety tests designed to demonstrate that modifications to the predicate device still meet existing specifications and standards, and that its performance is equivalent to the predicate. There is no mention of a human-in-the-loop study, expert ground truth establishment, or specific sample sizes for clinical data because this is a non-clinical performance evaluation for a monitoring spirometer, not an AI/software-as-a-medical-device (SaMD) study involving ground truth or human reader performance.
Therefore, many of the requested fields cannot be directly populated from the provided text as they are not applicable to the type of device and study described.
Here's the information that can be extracted or deduced from the provided document:
1. A table of acceptance criteria and the reported device performance
The document details performance changes and states they meet relevant standards. It frames the "acceptance criteria" not as novel thresholds, but as continued adherence to existing specifications and consensus standards.
| Feature / Parameter | Predicate Device (Gas Module SE, K062754) Specification | Subject Device (Gas Module 3) Reported Performance / Specification | Comparison Analysis / "Acceptance Criteria Met" |
|---|---|---|---|
| Warm-up Time | 2 minutes (CO2, O2, N2O); 5 minutes (anesthetic agents); 30 minutes (full specification) | 45 seconds (CO2, O2, N2O, anesthetic agents); 10 minutes (full specification) | Acceptance: "Similar, warm-up time improved in Gas Module 3." Implied acceptance is faster warm-up is better. |
| Sampling Rate | 200 ± 20ml/min | 200 ± 20ml/min (larger water trap); 120 ± 12ml/min (smaller water trap) | Acceptance: "Same - The flow rate for larger size water trap is the same. The option to use a new smaller size water trap is introduced which support a flow rate of 120ml/min, which may provide enhanced gas management for smaller sized patients." Implied acceptance for 120ml/min is meeting clinical needs for smaller patients. |
| CO2 Measurement Range | 0 to 15% | 0 to 10% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| DES Measurement Range | 0 to 20% | 0 to 18% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| SEV Measurement Range | 0 to 8% | 0 to 8% | Acceptance: No change, same. |
| ENF Measurement Range | 0 to 6% | 0 to 5% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| ISO Measurement Range | 0 to 6% | 0 to 5% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| HAL Measurement Range | 0 to 6% | 0 to 5% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| awRR Measurement Range | 4 to 60 rpm | 2 to 100 rpm | Acceptance: "The awRR measurement range for the subject device is wider than the predicate device. The awRR measurement range of the subject device has been tested using the test apparatus in figure 201.101 of ISO80601-2-55, and the test result meets the specification." Implied acceptance is broader range is beneficial and meets standards. |
| CO2 Accuracy | ± (0.2% + 2% of reading) | ± 0.1% @ 0-1%, ± 0.2% @ 1-5%, ± 0.3% @ 5-7%, ± 0.5% @ 7-10%, Unspecified @ >10% | Acceptance: "The CO2 measurement accuracy is now specified in different ranges. These accuracies in different ranges meet the requirements of ISO 80601-2-55." |
| O2 Accuracy | ± (1% + 2% of reading) | ± 1% @ 0-25%, ± 2% @ 25-80%, ± 3% @ 80-100% | Acceptance: "The O2 measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| N2O Accuracy | ± (1% + 2% of reading) | ± 2% @ 0-20%, ± 3% @ 20-100% | Acceptance: "The N2O measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| DES Accuracy | ± (0.15% + 5% of reading) | ± 0.1% @ 0-1%, ± 0.2% @ 1-5%, ± 0.4% @ 5-10%, ± 0.6% @ 10-15%, ± 1% @ 15-18%, Unspecified @ >18% | Acceptance: "The DES measurement accuracy is now specified in different ranges. These accuracies in different ranges still meet the requirements of ISO 80601-2-55." |
| SEV Accuracy | ± (0.15% + 5% of reading) | ± 0.15% @ 0-1%, ± 0.2% @ 1-5%, ± 0.4% @ 5-8%, Unspecified @ >8% | Acceptance: "The SEV measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| ENF Accuracy | ± (0.15% + 5% of reading) | ± 0.15% @ 0-1%, ± 0.2% @ 1-5%, Unspecified @ >5% | Acceptance: "The ENF measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| ISO Accuracy | ± (0.15% + 5% of reading) | ± 0.15% @ 0-1%, ± 0.2% @ 1-5%, Unspecified @ >5% | Acceptance: "The ISO measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| HAL Accuracy | ± (0.15% + 5% of reading) | ± 0.15% @ 0-1%, ± 0.2% @ 1-5%, Unspecified @ >5% | Acceptance: "The HAL measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| CO2 Rise Time |
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).